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

Not Applicable

Active, not recruiting

• Conditions: Acute Coronary Syndromes
• Interventions: Procedure: Intravascular ultrasound; Procedure: MRI

• Registration Number: NCT00798122
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-01
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Primary Completion: 2011-09-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women	MRI	IVUS and MRI performed in women with no obstructive CAD at angiography
Women	Intravascular ultrasound	IVUS and MRI performed in women with no obstructive CAD at angiography

Primary Outcome Measures

Name	Time	Method
IVUS and MRI findings	within one week of enrollment

Trial Locations

Locations (1)

NYU Medical Center and Bellevue Hospital Center; 🇺🇸 New York, New York, United States