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Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease (SWAN)
This study is currently recruiting participants.
Verified by New York University School of Medicine, November 2008
Sponsors and Collaborators: New York University School of Medicine
Doris Duke Charitable Foundation
Information provided by: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00798122
  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

MedlinePlus related topics: Coronary Artery Disease Heart Attack Ultrasound
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Single Group Assignment
Official Title: Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • IVUS and MRI findings [ Time Frame: within one week of enrollment ] [ Designated as safety issue: No ]

Study Start Date: March 2006
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Women: Experimental
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:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798122

Contacts
Contact: Harmony R Reynolds, MD 212-263-6958 harmony.reynolds@nyumc.org

Locations
United States, New York
NYU Medical Center and Bellevue Hospital Center Recruiting
New York, New York, United States, 10016
Principal Investigator: Harmony R Reynolds, MD            
Sub-Investigator: Judith S Hochman, MD            
Sponsors and Collaborators
New York University School of Medicine
Doris Duke Charitable Foundation
  More Information

Responsible Party: New York University School of Medicineq ( Harmony R. Reynolds, MD )
Study ID Numbers: DD CSDA 2006066
Study First Received: November 24, 2008
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00798122  
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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009