WO2004023102A2 - Methods of detection of progression of stenosis - Google Patents
Methods of detection of progression of stenosis Download PDFInfo
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- WO2004023102A2 WO2004023102A2 PCT/US2003/028154 US0328154W WO2004023102A2 WO 2004023102 A2 WO2004023102 A2 WO 2004023102A2 US 0328154 W US0328154 W US 0328154W WO 2004023102 A2 WO2004023102 A2 WO 2004023102A2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
- A61B6/50—Clinical applications
- A61B6/504—Clinical applications involving diagnosis of blood vessels, e.g. by angiography
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
- A61B6/48—Diagnostic techniques
- A61B6/481—Diagnostic techniques involving the use of contrast agents
Abstract
The present invention is directed toward methods of identifying progression of coronary stenosis in a patient over a time interval of interest. In various embodiments, first and second angiograms are performed in a region of interest in a patient to produce first and second sets of angiographic data, where the second set of angiographic data reflects passage of a time interval of interest after performing the first angiogram. The first set of angiographic data is compared (120) to the second set of angiographic data to determine whether stenosis is progressing in the region of interest.
Description
TITLE: METHODS OF DETECTION OF PROGRESSION OF STENOSIS
Inventors: S. Ward Cassecells; Khaled Hassan; Moein Vaseghi; Mir Said Siadaty; Morteza Naghavi; Richard Kirkeeide; Mohammad Hassan; Mohammad Madjid
PRIORITY INFORMATION
[0001] This application claims the benefit of U.S. Provisional Application No.
60/409,068 filed on September 9, 2002.
FIELD OF INVENTION
[0002] The present invention relates generally to detection of conditions in living tissue. More specifically, the present invention is directed toward one or more methods of identifying and/or determining progression of stenosis in a patient over a time interval of interest.
BACKGROUND OF THE INVENTION
[0003] Angiographic predictors of plaque progression are weak and few and may include length, irregular surface, turbulence, low share, and, in some cases, eccentricity and calcification. The plaque may be interpreted as a fissured surface or neovacularization.
Progression may be predicted by "plaque blush."
[0004] Mild to moderate coronary artery disease (defined as 50% or less diameter stenosis by visual estimation at cineangiography) is usually not considered severe enough to cause myocardial ischemia and therefore is not considered a candidate for revascularization.
However, it is clear that the apparent percent stenosis does not correlate very well with hemodynamic measurements. Coronary atherosclerosis progression does not follow a linear trend and, moreover, lesions may exhibit spasm or may progress gradually or abruptly, causing unstable angina and/or myocardial infarction. Accordingly, it would be of great clinical importance to be able to predict which coronary lesions will significantly progress over time.
[0005] New technologies such as intravascular ultrasound, magnetic resonance imaging (MP ), intra coronary infrared (IR) thermoscopy, and near-IR spectroscopy are being developed to answer this question. However, coronary cineangiography is widely available, and permits simultaneous lesion-specific therapy.
[0006] Nonetheless, since the development of angiography in the early 1960s, it has become a standard practice in angiography to describe coronary artery obstruction mainly in terms of their location and the degree of luminal narrowing. However, other morphological characteristics are indicators of unstable lesions. It is known that there is a strong relationship between complicated stenosis as determined angiographically and histologic features of plaque rupture, plaque hemorrhage, superimposed partially occluding thrombi, or recanalized thrombi. These pathological features often correspond to a distinctive angiographic appearance characterized by eccentric, irregular, and shaggy borders with intramural haziness.
[0007] In addition to cross-sectional correlations, several groups have examined the prognostic impact of plaque morphology in retrospective studies. Studies have also concluded that cardiac events were somewhat more frequent in patients with coronary thrombus and /or complex coronary morphology. Lesions are also more likely to progress if they are long, irregular, or highly stenotic. There is also some evidence that progression is more likely if the lesion's location or shape causes non-linear flow with shear stress that is unusually high (e.g., very high velocity caused by tight lesions can activate platelets by high shear stress), or low (stasis or "silt effect" of slow or turbulent flow).
[0008] There is a need for a screening test that would allow early identification of coronary artery disease in its asymptomatic stage using a noninvasive screening tool.
SUMMARY OF THE INVENTION
[0009] The present invention is directed toward one or more methods of identifying and or determining progression of stenosis in a patient over a time interval of interest. First and second angiograms may be performed in a region of interest in a patient to produce a first and second set of angiographic data where the second set of angiographic data reflect waiting a time interval of interest after performing the first angiogram. The first set of angiographic data may then be compared to the second set of angiographic data to determine whether stenosis in progressing in the region of interest.
[0010] Alternatively, the first and second sets of angiographic data may be analyzed to determine whether stenosis in progressing in the region of interest where the analysis may indicate the presence of plaque blush, the presence of at least one branch point lesion, the presence of arterial calcification, or the like, or a combination thereof.
[0011] The region of interest, i.e. the area of the angiogram, may be coronary.
[0012] It is emphasized that this summary is not to be interpreted as limiting the scope of these inventions which are limited only by the claims herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Fig. 1 is a block diagram of a first preferred method.
[0014] Fig. 2 is a block diagram of a second preferred method.
[0015] Fig. 3 is a block diagram of a third preferred method.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION
[0016] Autopsy studies have demonstrated that 80% to 90% of fatal myocardial infarcts reveal a fresh thrombus, usually occlusive or sub-occlusive. Of these, 60-70% overlie a thin, ruptured fibrous cap. Most of these are infiltrated by macrophages whose metalloproteinases are capable of digesting the cap and inhibiting the metabolism and proliferation of smooth muscle cells (or killing them by apoptosis), thereby preventing
synthesis of the matrix collagens and proteoglycans that constitute the fibrous cap. Other studies have also reported evidence of plaque angiogenesis, presumably in response to plaque hypoxia and/ or inflammation. Angiogenesis is characterized by venules and capillaries that, until they mature, are hyperpermeable. Several studies suggested that neovascularization in the walls of coronary arteries is associated with the presence of atherosclerotic plaque. Although the mechanisms responsible for the formation of these intraplaque microvessels are not understood well, intraplaque angiogenesis was found to play an important role in the development and progression of coronary artery lesions.
[0017] The other 30-40% of thrombosed plaques are found, at autopsy, to have a cap which is not ruptured but whose surface is eroded (lined by macrophages and denuded of endothelium).
[0018] Therefore, both types of vulnerable plaque may be described as "leaky" as evidenced by lesions which retain angiographic contrast material for 2 or 3 seconds after the "dye column" has passed down the artery. Some of these "blushing lesions" were due to gravitation-pooling in a deep ulcer or at the bottom of a curved region. However, others were not, being superior in location.
[0019] As used herein, a "plaque blush" means a hemodynamically non-critical
(<50% diameter stenosis) lesion likely to progress.
[0020] Referring now to Fig. 1, in a first preferred method progression of stenosis in a patient over a time interval of interest may be identified by performing a first angiogram in a region of interest in a patient to produce a first set of angiographic data (illustrated at step 100); performing a second angiogram in the region of interest in the patient to produce a second set of angiographic data after waiting a time interval of interest after performing the first angiogram (illustrated at step 110); and comparing the first set of angiographic data to
the second set of angiographic data to determine whether stenosis in progressing in the region of interest (illustrated at step 120).
[0021] The time interval of interest may be in the range of 125 to 145 days. The region of interest may comprise the patient's coronary system.
[0022] Comparing may include comparing a diameter of stenosis in the first and second sets of angiographic data to each other, e.g. the diameter of stenosis in the region of interest as described by the first set of angiographic data to a corresponding datum in the second set of angiographic data.
[0023] That stenosis is progressing may be determined where the first set of angiographic data indicates the presence of a diseased vessel. In such a case, a progression of stenosis may be determined where comparison indicates an increase of at least 20% in the absolute diameter of stenosis as indicated from comparing the first set of angiographic data to the second set of angiographic data.
[0024] Additionally, a determination that stenosis is progressing may be accomplished where the first set of angiographic data indicates the presence of a normal vessel and comparison indicates an increase of at least 30%> in the absolute diameter of stenosis as indicated from comparing the first set of angiographic data to the second set of angiographic data.
[0025] The second set of angiographic data may comprise data indicating the existence of plaque blush, the existence of a branch point lesion, the existence of arterial calcification, or the like, or a combination thereof. Comparing may therefore comprise comparing data between the two data sets where the data indicate the existence of plaque blush, data indicating the existence of a branch point lesion, data indicating the existence of arterial calcification, or the like, or a combination thereof, provided that these data exist in both sets of angiographic data.
[0026] In a second preferred method, referring now to Fig. 2, progression of stenosis in a patient over a time interval of interest may be identified by performing a first angiogram in a region of interest in the a patient to produce a first set of angiographic data (illustrated at step 200); performing a second angiogram in the region of interest in the patient to produce a second set of angiographic data after waiting a time interval of interest after performing the first angiogram (illustrated at step 210); and analyzing the first and second sets of angiographic data to determine whether stenosis in progressing in the region of interest (illustrated at step 220).
[0027] The time interval of interest is in the range of 125 to 145 days. The region of interest may comprise the patient's coronary system.
[0028] In currently contemplated embodiments, the first and second angiographies may be biplane angiographies.
[0029] Analyzing may further comprise determining whether the second set of angiographic data indicates the presence of plaque blush, the presence of at least one branch point lesion, the presence of arterial calcification, or the like, or a combination thereof. Analyzing may further comprise calculating an odds ration, ("OR"). The following formula may be used to calculate the OR:
OR = e (2-5*BL + 1-815*CA + 2.6337*BR)
where BL is 0.5 if plaque plush is detected or -0.5 if plaque blush is not detected, CA is 0.5 if arterial calcification is detected or -0.5 if arterial calcification is not detected, and BR is 0.5 if at least one branch point lesion is detected and -0.5 if at least one branch point lesion is detected from the analyzing.
[0030] Analyzing may further comprise comparing a diameter of stenosis in the first and second sets of angiographic data.
[0031] Referring now to Fig. 3, in a third preferred embodiment progression of coronary stenosis in a patient over a time interval of interest may be identified by performing a first coronary angiogram in the a patient to produce a first set of angiographic data (illustrated at step 300); performing a second coronary angiogram in the patient to produce a second set of angiographic data after waiting a time interval of interest after performing the first angiogram (illustrated at step 310); and analyzing the first and second sets of coronary angiographic data to determine whether stenosis in progressing in the region of interest (illustrated at step 320).
[0032] It will be understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated above in order to explain the nature of this invention may be made by those skilled in the art without departing from the principle and scope of the invention as recited in the appended claims. STATEMENT OF INDUSTRIAL USE
[0033] The present invention may be used for detection of progression of coronary stenosis in a patient over a time interval of interest.
Claims
1. A method of identifying progression of stenosis in a patient over a time interval of interest, comprising: a. performing a first angiogram in a region of interest in a patient to produce a first set of angiographic data; b. performing a second angiogram in the region of interest in the patient to produce a second set of angiographic data after waiting a time interval of interest after performing the first angiogram; and c. comparing the first set of angiographic data to the second set of angiographic data to determine whether stenosis in progressing in the region of interest.
2. The method of claim 1, wherein the comparing further comprises comparing a diameter of stenosis in the first and second sets of angiographic data.
3. The method of claim 2, further comprising determining that stenosis is progressing where the first set of angiographic data indicates the presence of a diseased vessel and the comparison indicates an increase of at least 20% in the absolute diameter of stenosis as indicated from comparing the first set of angiographic data to the second set of angiographic data.
4. The method of claim 2, further comprising determining that stenosis is progressing where the first set of angiographic data indicates the presence of a normal vessel and the comparison indicates an increase of at least 30% in the absolute diameter of stenosis as indicated from comparing the first set of angiographic data to the second set of angiographic data.
5. The method of claim 1, wherein the time interval of interest is in the range of 125 to 145 days.
6. The method of claim 1, wherein the second set of angiographic data comprises data indicating the existence of plaque blush.
7. The method of claim 6, wherein the comparing comprises comparing data indicating the existence of plaque blush.
8. The method of claim 7, wherein the second set of angiographic data comprises data indicating the existence of a branch point lesion.
9. The method of claim 8, wherein the comparing comprises comparing data indicating the existence of a branch point lesion.
10. The method of claim 9, wherein the second set of angiographic data comprises data indicating the existence of arterial calcification.
11. The method of claim 10, wherein the comparing comprises comparing data indicating the existence of arterial calcification.
12. The method of claim 1, wherein the region of interest is the coronary system.
13. A method of identifying progression of stenosis in a patient over a time interval of interest: a. performing a first angiogram in a region of interest in a patient to produce a first set of angiographic data; b. performing a second angiogram in the region of interest in the patient to produce a second set of angiographic data after waiting a time interval of interest after performing the first angiogram; and c. analyzing the first and second sets of angiographic data to determine whether stenosis in progressing in the region of interest.
14. The method of claim 13, wherein the analyzing comprises determining whether the second set of angiographic data indicates at least one of (i) the presence of plaque blush, (ii) at least one branch point lesion, or (iii) arterial calcification
15. The method of claim 14, wherein the analyzing comprises calculating an odds ratio ("OR") using the following formula:
OR = e (2'5*BL + 1-815*CA + 2.6337*BR)
where BL is 0.5 if plaque plush is detected or -0.5 if plaque blush is not detected, CA is 0.5 if arterial calcification is detected or -0.5 if arterial calcification is not detected, and BR is 0.5 if at least one branch point lesion is detected and -0.5 if at least one branch point lesion is detected from the analyzing.
16. The method of claim 13, wherein the time interval of interest is in the range of 125 to 145 days.
17. The method of claim 13, wherein the analyzing comprises comparing a diameter of stenosis in the first and second sets of angiographic data.
18. The method of claim 13, wherein the region of interest is the coronary system.
19. The method of claim 18, wherein the first and second angiographies are biplane angiographies.
20. A method of identifying progression of coronary stenosis in a patient over a time interval of interest: a. performing a first coronary angiogram in a patient to produce a first set of angiographic data; b. performing a second coronary angiogram in the patient to produce a second set of angiographic data after waiting a time interval of interest after performing the first angiogram; and c. analyzing the first and second sets of coronary angiographic data to determine whether stenosis in progressing in the region of interest.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US40906802P | 2002-09-09 | 2002-09-09 | |
| US60/409,068 | 2002-09-09 |
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| Publication Number | Publication Date |
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| WO2004023102A2 true WO2004023102A2 (en) | 2004-03-18 |
| WO2004023102A3 WO2004023102A3 (en) | 2004-06-24 |
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| Application Number | Title | Priority Date | Filing Date |
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| PCT/US2003/028154 WO2004023102A2 (en) | 2002-09-09 | 2003-09-09 | Methods of detection of progression of stenosis |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113040812A (en) * | 2021-02-03 | 2021-06-29 | 上海联影医疗科技股份有限公司 | Medical image analysis method, medical image analysis apparatus, computer device, and storage medium |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4692864A (en) * | 1985-05-23 | 1987-09-08 | Elscint Ltd. | Method of determining stenosis of blood vessels |
| US5637575A (en) * | 1988-01-19 | 1997-06-10 | The Trustees Of The University Of Pennsylvania | Methods of inhibiting restenosis |
| US6377832B1 (en) * | 1998-03-20 | 2002-04-23 | Georgia Tech Research Corporation | System and method for analyzing a medical image |
-
2003
- 2003-09-09 WO PCT/US2003/028154 patent/WO2004023102A2/en active Application Filing
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4692864A (en) * | 1985-05-23 | 1987-09-08 | Elscint Ltd. | Method of determining stenosis of blood vessels |
| US5637575A (en) * | 1988-01-19 | 1997-06-10 | The Trustees Of The University Of Pennsylvania | Methods of inhibiting restenosis |
| US6377832B1 (en) * | 1998-03-20 | 2002-04-23 | Georgia Tech Research Corporation | System and method for analyzing a medical image |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113040812A (en) * | 2021-02-03 | 2021-06-29 | 上海联影医疗科技股份有限公司 | Medical image analysis method, medical image analysis apparatus, computer device, and storage medium |
| CN113040812B (en) * | 2021-02-03 | 2023-08-22 | 上海联影医疗科技股份有限公司 | Medical image analysis method, medical image analysis device, computer equipment and storage medium |
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| Publication number | Publication date |
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| WO2004023102A3 (en) | 2004-06-24 |
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