Sex Differences in Coronary Pathophysiology



Status:Recruiting
Conditions:Angina, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:June 2007
Contact:Homa Tavana
Email:htavana@cvmed.stanford.edu
Phone:(650) 721-5540

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

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.

Women are more likely than men to have chest pain suggestive of angina but normal-appearing
coronary arteries on angiography, which ultimately imparts a significant morbidity/mortality
and economic burden. Recent evidence suggests that women commonly have endothelial and
microcirculatory dysfunction, as well as diffusely distributed atherosclerosis--disorders
that can cause chest pain, but will not be seen on angiography. This presents an intriguing
basis for pathophysiologic differences between women and men, but there are no studies that
actually compare the presence of such findings in women with that of men. The objective of
this research project is to determine if the incidence of such pathophysiologic differences
is truly higher in women than it is in men.

We hope to determine if there is a higher incidence of diffuse atherosclerotic plaque,
endothelial dysfunction, and/or microcirculatory dysfunction in women compared with men. If
this sex difference exists, it has significant implications for how we should be testing and
treating women with chest pain but angiographically normal coronary arteries.

Inclusion Criteria:

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) 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)
We found this trial at
1
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
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