Differences in Epicardial Plaque and Microvascular Function in Women With an Acute Myocardial Infarction

Study Overview
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Brief Summary
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The broad objective is to advance our understanding of both in vivo anatomical and functional changes that are present in the coronary arteries in women who have an acute coronary syndrome. Specific focus will be placed on the age of the women as there may be distinct differences in younger women (< 50 years) given the marked increase in mortality in this population.

Detailed Description
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The hypothesis of the current study is that plaque erosion and microvascular dysfunction are key features responsible for the increased peri-MI mortality in young women. In order to test this hypothesis the following specific aims are proposed using a special intravascular ultrasound technique called virtual histology and microvascular function (effect of intracoronary adenosine on coronary blood flow) in patients coming to the cardiac catheterization laboratory with an acute MI: To determine if plaque rupture or plaque erosion is more prevalent in young women (<50 years) compared with older women (≥ 50 years) and men in the development of an acute MI To determine if inflammatory mediators of plaque rupture are higher in older women and men with an acute MI compared with younger women To determine if microvascular function is abnormal in young women undergoing percutaneous coronary revascularization with an acute MI compared to older women and men To determine if alterations exist in the number and function of EPCs in young women (<50 years) compared with older women (≥ 50 years) and men who have had an acute MI and to determine the association with microvascular function

Official Title
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Differences in Epicardial Plaque and Microvascular Function in Women With an Acute Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: IVUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years or older Acute coronary syndrome defined as at least two of the following: A) an elevated cardiac biomarker (troponin or CK-MB), B) new or dynamic ECG changes in at least 2 contiguous standard electrocardiographic leads of ST depression > 1 mm or ST elevation of >1 mm or T-wave inversions, C) chest pain or discomfort of at least 15 minutes duration, D) a new wall motion abnormality by echocardiography Patient who is undergoing coronary angiography Physician planning to perform IVUS for treatment of the infarct-related vessel Exclusion Criteria: Creatinine > 2.0 mg/dL (most recent) Hemodynamically unstable patients (systolic blood pressure < 90 mmHg or heart rate > 110 beats/ minute or presence of an intra-aortic balloon pump) Coronary revascularization (percutaneously or surgically) within 6 months The use of chronic immunosuppressive agents No target lesion was found at the time of cardiac catheterization that will be percutaneously intervened upon (the patient must undergo percutaneous coronary intervention) Inability to give informed consent Pregnant or lactating women Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gender comparison | Procedure: IVUS<br>* Intravascular ultrasound with virtual histology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Virtual Histology |  | Performed during PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Progenitor Cells |  | Collected immediately pre PCI | 
| Microvascular function in the noninfarct related vessel |  | Assessed immediately post PCI | 
| Virtual Histology in noninfarct related vessel |  | Assessed immediately post PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Women