Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease (SWAN)
Primary Purpose
Acute Coronary Syndromes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intravascular ultrasound
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndromes focused on measuring sex, acute coronary syndromes, normal angiogram, no obstruction at angiography, women
Eligibility 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
Sites / Locations
- NYU Medical Center and Bellevue Hospital Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Women
Arm Description
IVUS and MRI performed in women with no obstructive CAD at angiography
Outcomes
Primary Outcome Measures
IVUS and MRI findings
Secondary Outcome Measures
Full Information
NCT ID
NCT00798122
First Posted
November 24, 2008
Last Updated
August 29, 2023
Sponsor
NYU Langone Health
Collaborators
Doris Duke Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00798122
Brief Title
Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease
Acronym
SWAN
Official Title
Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2006 (Actual)
Primary Completion Date
September 6, 2011 (Actual)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Doris Duke Charitable Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
sex, acute coronary syndromes, normal angiogram, no obstruction at angiography, women
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Women
Arm Type
Experimental
Arm Description
IVUS and MRI performed in women with no obstructive CAD at angiography
Intervention Type
Procedure
Intervention Name(s)
Intravascular ultrasound
Intervention Description
intravascular ultrasound
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
cardiac MRI
Primary Outcome Measure Information:
Title
IVUS and MRI findings
Time Frame
within one week of enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harmony Reynolds, M.D.
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Medical Center and Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21900087
Citation
Reynolds HR, Srichai MB, Iqbal SN, Slater JN, Mancini GB, Feit F, Pena-Sing I, Axel L, Attubato MJ, Yatskar L, Kalhorn RT, Wood DA, Lobach IV, Hochman JS. Mechanisms of myocardial infarction in women without angiographically obstructive coronary artery disease. Circulation. 2011 Sep 27;124(13):1414-25. doi: 10.1161/CIRCULATIONAHA.111.026542. Epub 2011 Sep 6.
Results Reference
derived
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Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease
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