Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease

Study Overview
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Brief Summary
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Approximately 600,000 women are treated for acute coronary syndrome (ACS) annually in the US. ACS includes heart attack and a milder form called unstable angina. Many of these women have angiograms of which 14-39% show no significant coronary artery disease (CAD, cholesterol plaque accumulation in arteries of the heart). The remaining majority of women with ACS have cholesterol plaque buildup which appears severe enough on angiography to limit blood flow to the heart. It is difficult to advise women with heart attacks and no major heart artery blockages on what to do if chest pain happens again. Additional studies are needed to find out why this sort of heart attack happens and to help doctors understand how to treat patients who have this problem in the best possible way. Some women with heart attacks who have no major blockage in heart arteries have cholesterol plaque in the arteries of the heart cannot be seen on angiography but can be seen using a newer technique called intravascular ultrasound (IVUS). IVUS involves creating pictures of the artery walls using ultrasound (sound waves) from within the artery itself. In some women without major heart artery blockage, heart attack is caused by low blood flow due to disease of smaller blood vessels which cannot be seen on angiography or IVUS. This problem can be found using magnetic resonance imaging (MRI), which can show blood flow to the heart. MRI may also be used to show where the heart has been damaged. The pattern of damage could suggest that a heart attack in a woman, who has no badly blocked heart arteries, happened for one (or more) of these reasons or another reason. The Study of Women with ACS and Non-obstructive CAD (SWAN) will use IVUS and MRI to help determine the reasons for heart attacks in women with no major blockages in heart arteries.

Official Title
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Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease

Conditions
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Acute Coronary Syndromes

Intervention / Treatment
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* Procedure: Intravascular ultrasound
* Procedure: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women positive cardiac markers and/or ST elevation scheduled for angiography Exclusion Criteria: prior diagnosis of obstructive CAD contraindication to IVUS and/or MRI use of vasospastic agent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women<br>IVUS and MRI performed in women with no obstructive CAD at angiography | Procedure: Intravascular ultrasound<br>* intravascular ultrasound<br>Procedure: MRI<br>* cardiac MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVUS and MRI findings |  | within one week of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sex, acute coronary syndromes, normal angiogram, no obstruction at angiography, women