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Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease (SWAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00798122
Recruitment Status : Active, not recruiting
First Posted : November 25, 2008
Last Update Posted : November 3, 2022
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Procedure: Intravascular ultrasound Procedure: MRI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease
Actual Study Start Date : March 1, 2006
Actual Primary Completion Date : September 6, 2011
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Women
IVUS and MRI performed in women with no obstructive CAD at angiography
 Procedure: Intravascular ultrasound
intravascular ultrasound

Procedure: MRI
cardiac MRI


Outcome Measures
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Primary Outcome Measures :
  1. IVUS and MRI findings [ Time Frame: within one week of enrollment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798122


Locations
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United States, New York
NYU Medical Center and Bellevue Hospital Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Doris Duke Charitable Foundation
Investigators
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Principal Investigator: Harmony Reynolds, M.D. NYU Langone Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00798122    
Other Study ID Numbers: 07-050
DD CSDA 2006066 ( Other Grant/Funding Number: DORIS DUKE CHRTBL FND )
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
sex
acute coronary syndromes
normal angiogram
no obstruction at angiography
women
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Syndrome
Disease
 Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases