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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Harmony R. Reynolds, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00798122
First received: November 24, 2008
Last updated: November 20, 2013
Last verified: November 2013
  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

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (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
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
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, see Learn About Clinical Studies.

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

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: November 20, 2013
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 August 28, 2014