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

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Procedure: IVUS

• Registration Number: NCT00587002
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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:

1. 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

2. To determine if inflammatory mediators of plaque rupture are higher in older women and men with an acute MI compared with younger women

3. To determine if microvascular function is abnormal in young women undergoing percutaneous coronary revascularization with an acute MI compared to older women and men

4. 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	IVUS	Gender comparison

Primary Outcome Measures

Name	Time	Method
Plaque Virtual Histology	Performed during PCI

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States