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

NCT ID: NCT00798122

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-01

Study Completion Date

2027-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Women

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

Group Type EXPERIMENTAL

Intravascular ultrasound

Intervention Type PROCEDURE

intravascular ultrasound

MRI

Intervention Type PROCEDURE

cardiac MRI

Interventions

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Intravascular ultrasound

intravascular ultrasound

Intervention Type PROCEDURE

MRI

cardiac MRI

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Doris Duke Charitable Foundation

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harmony Reynolds, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Medical Center and Bellevue Hospital Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21900087 (View on PubMed)

Other Identifiers

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DD CSDA 2006066

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

07-050

Identifier Type: -

Identifier Source: org_study_id

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