Active — Not RecruitingNot Applicable

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

United States50 participantsStarted 2006-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is specifically looking at women with acute coronary syndromes who have nonobstructive coronary artery disease — does my situation match that profile, and is that distinction important for how my condition would be treated?
2Since this trial is 'active but not recruiting,' does that mean there's no chance of me joining it, and if so, are there similar studies currently enrolling that my doctor thinks might be worth looking into?
3The study is measuring IVUS and MRI findings — can you explain what those imaging tests involve, how they might give us useful information about my heart, and whether I could get those same tests outside of a clinical trial?
4This trial doesn't seem to be testing a specific drug or procedure, but rather gathering detailed imaging data — does that mean participation would mainly involve diagnostic tests rather than a new treatment, and how would that affect my actual care?
5Given that this study focuses on women with this specific type of coronary disease, what does the existing research tell us about why women with nonobstructive coronary artery disease are being studied separately, and how might those findings influence the treatment options you'd recommend for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

IVUS and MRI findings

Timeframe: within one week of enrollment

Trial details

NCT IDNCT00798122

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-09-06

View on ClinicalTrials.gov More Acute Coronary Syndromes trials