Sex Differences in Coronary Pathophysiology

Trial ID or NCT#

NCT00823563

Status

recruiting iconRECRUITING

Purpose

This is a research study evaluating possible causes of chest pain (or an anginal equivalent, such as fatigue resulting in a decrease in exercise tolerance, shortness of breath, or back, shoulder, neck, or jaw pain) in people with no evidence of significant coronary artery disease on their coronary angiogram (pictures of the blood vessels in the heart). The purpose of the research study is to determine if there is diffuse atherosclerosis (plaque) not appreciated by angiography, or if the coronary endothelium (lining of the blood vessels in the heart) and/or microcirculation (small vessels in the heart that are not easily seen with an angiogram) are not functioning properly in those who have chest pain (or an anginal equivalent), but normal coronary arteries on angiography. Specifically, we are interested if these findings are more common in women than men.

Official Title

Sex Differences in Symptomatic Non-Obstructive Coronary Disease: Do Women Have a Unique Coronary Pathophysiology?

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Patient referred for elective coronary angiography because of a reasonable clinical suspicion of coronary ischemia. 2. Presence of angina or an anginal equivalent (including chest, back, shoulder, arm, neck, jaw discomfort, or shortness of breath brought on by physical exertion, emotional stress, or certain times of day/month).
Exclusion Criteria:
  1. 1) Asymptomatic (such as a pre-op cath) 2) Status-post heart transplant 3) Status-post coronary artery bypass grafting 4) Age <18 5) Renal insufficiency (creatinine >1.5) 6) Presence of an acute coronary syndrome (STEMI or NSTEMI), Tako-tsubo, an abnormal ejection fraction (EF<55%), cardiogenic shock, or recent VT/VF 7) Presence of another likely explanation of chest pain, such as pulmonary hypertension or aortic stenosis 8) History of adverse reaction to any of the medications being used (acetylcholine, nitroglycerin, adenosine, or heparin) 9) Currently taking vasoactive medication (such as nitroglycerin) 10) Inability to provide an informed consent, including an inability to speak, read, or understand English, Spanish, Chinese, Farsi, Japanese, Korean, Russian, or Vietnamese 11) A hearing impairment that won't allow for a typical verbal conversation or a visual impairment that won't allow for reading of the written consent 12) Participation in another study (with the exception of the Stanford Gene-PAD study) 13) A potentially vulnerable subject (including minors, pregnant women, economically and educationally disadvantaged, decisionally impaired, and homeless people)

Investigator(s)

Jennifer Tremmel
Jennifer Tremmel
Interventional cardiologist, Cardiologist
Susan P. and Riley P. Bechtel Medical Director and Associate Professor of Medicine (Cardiovascular Medicine)
Alan Yeung, MD
Alan Yeung, MD
Interventional cardiologist, Cardiologist
Li Ka Shing Professor in Cardiology
Marcia L. Stefanick, Ph.D.

Contact us to find out if this trial is right for you.

Contact

Homa Tavana
650-721-5540