Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease

NCT00798122 | Active Not Recruiting DMC

• 2 other identifiers: 07-050DD CSDA 2006066
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndromes

Keywords

sex; acute coronary syndromes; normal angiogram; no obstruction at angiography; women

Outcome Measures

Primary Outcomes (1)

• IVUS and MRI findings

  within one week of enrollment

Study Arms (1)

Women

EXPERIMENTAL

IVUS and MRI performed in women with no obstructive CAD at angiography

Procedure: Intravascular ultrasound; Procedure: MRI

Interventions

Intravascular ultrasound PROCEDURE

intravascular ultrasound

Women

MRI PROCEDURE

cardiac MRI

Women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women
• positive cardiac markers and/or ST elevation
• scheduled for angiography

You may not qualify if:

• prior diagnosis of obstructive CAD
• contraindication to IVUS and/or MRI
• use of vasospastic agent

Sponsors & Collaborators

• NYU Langone Health: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

NYU Medical Center and Bellevue Hospital Center

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 21900087 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Coitus

Interventions

Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Harmony Reynolds, M.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: March 1, 2006
• Primary Completion: September 6, 2011
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

US (1)