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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00798122
First Posted: November 25, 2008
Last Update Posted: May 8, 2017
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.
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
New York University School of Medicine
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease

Resource links provided by NLM:


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 ]

Estimated Enrollment: 50
Actual Study Start Date: March 1, 2006
Estimated Study Completion Date: June 1, 2022
Estimated Primary Completion Date: June 1, 2022 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, New York
NYU Medical Center and Bellevue Hospital Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Harmony Reynolds, M.D. New York University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00798122     History of Changes
Other Study ID Numbers: 07-050
DD CSDA 2006066 ( Other Grant/Funding Number: DORIS DUKE CHRTBL FND )
First Submitted: November 24, 2008
First Posted: November 25, 2008
Last Update Posted: May 8, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
sex
acute coronary syndromes
normal angiogram
no obstruction at angiography
women

Additional relevant MeSH terms:
Syndrome
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases