Cardiac Autonomic Function in Women with Microvascular Coronary Dysfunction (NCT01568177) | Clinical Trial Compass
CompletedNot Applicable
Cardiac Autonomic Function in Women with Microvascular Coronary Dysfunction
United States105 participantsStarted 2011-02
Plain-language summary
Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Autonomic nervous system (ANS) is part of the central nervous system to help people adapt to changes in their environment. It controls what are normally involuntary activities, such as heart rate, respiration (breathing), body temperature, blood pressure, and urinary function. However, there is a limited understanding of the role of ANS in MCD. This research is proposed to investigate cardiovascular reactivity to mental stress and the cardiac (heart) nervous system in women with MCD using mental stress testing, peripheral vascular testing, advanced cardiac imaging and cardiac autonomic function testing. 100 participants will be recruited in the next five years.
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:
Inclusion criteria for Protocol 14906:
* Women with symptomatic angina or angina equivalent;
* Age \> 18 yrs old;
* No obstructive CAD at coronary angiography (performed within the previous 24 months);
* Competent to give informed consent.
Inclusion criteria for Protocol 11753:
* Women without signs and symptoms of myocardial ischemia (chest pain, abnormal stress testing, abnormal noninvasive testing);
* No cardiac risk factors by Framingham/NCEP criteria;
* Age (35-65) matched to the WISE MCD population;
* A normal maximal exercise stress test.
Exclusion Criteria:
Exclusion criteria for Protocol 14906:
* Obstructive CAD greater than or equal to 50% luminal diameter stenosis in greater than or equal to 1 epicardial coronary artery;
* Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000);
* Primary valvular heart disease clearly indicating the need for valve repair or replacement;
* Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
* Prior or planned percutaneous coronary intervention or CABG;
* Acute MI;
* Prior non-cardiac illness with an estimated life expectancy \< 4 years;
* Unable to give informed consent;
* Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
* Contraindications to CMRI (e.g., AICD, pacemaker, untreatable claustrophobia or known angio-edema);
* Women with intermediate coronary stenoses (\> 20% but \< 50% luminal diameter s…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.