Clinical trial NCT00798122: Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease
Official title: Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Coronary Syndromes
Keywords: sex
acute coronary syndromes
normal angiogram
no obstruction at angiography
women
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2008-11-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: IVUS and MRI findings
timeFrame: within one week of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Medical Center and Bellevue Hospital Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Harmony Reynolds, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.