Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease (SWAN)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndromes |
Procedure: Intravascular ultrasound Procedure: MRI |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease |
- IVUS and MRI findings [ Time Frame: within one week of enrollment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Women
IVUS and MRI performed in women with no obstructive CAD at angiography
|
Procedure: Intravascular ultrasound
intravascular ultrasound
Procedure: MRI
cardiac MRI
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| NYU Medical Center and Bellevue Hospital Center | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Harmony Reynolds, M.D. | New York University School of Medicine |
More Information
No publications provided by New York University School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Harmony R. Reynolds, Assistant Professor of Medicine, Associate Director, Cardiovascular Clinical Research Center, New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00798122 History of Changes |
| Other Study ID Numbers: | DD CSDA 2006066 |
| Study First Received: | November 24, 2008 |
| Last Updated: | October 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
sex acute coronary syndromes normal angiogram no obstruction at angiography women |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Heart Diseases Cardiovascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013