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Sex Differences in Coronary Pathophysiology

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ClinicalTrials.gov Identifier: NCT00823563
Recruitment Status : Recruiting
First Posted : January 15, 2009
Last Update Posted : July 6, 2022
Information provided by (Responsible Party):
Jennifer A Tremmel, MD, MS, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment
Chest Pain Ischemia Procedure: 30 cc blood draw Procedure: Intravascular ultrasound (IVUS) Procedure: Coronary pressure/flow wire testing Procedure: Coronary pressure/flow testing: Acetycholine challenge Procedure: Procedure: Coronary pressure/flow testing: Nitroglycerin challenge Procedure: Procedure: Procedure: Coronary pressure/flow testing: Adenosine challenge

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 126 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sex Differences in Symptomatic Non-Obstructive Coronary Disease: Do Women Have a Unique Coronary Pathophysiology?
Study Start Date : June 2007
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Primary Outcome Measures :
  1. Sex Differences in Endothelial Dysfunction, Microvascular Dysfunction, and Diffuse Plaque [ Time Frame: Immediately ]

Secondary Outcome Measures :
  1. Cardiovascular Outcomes [ Time Frame: 3 years and 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult women and men with angina who have been referred for an elective coronary angiogram because of a reasonable clinical suspicion of coronary ischemia.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823563

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Contact: Homa Tavana (650) 721-5540 htavana@cvmed.stanford.edu

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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Homa Tavana    650-721-5540    htavana@cvmed.stanford.edu   
Contact: Jennifer Tremmel, MD    (650) 723-0180      
Principal Investigator: Jennifer Ann Tremmel         
Sub-Investigator: Marcia L. Stefanick Ph.D.         
Study Chair: Alan Ching Yuen Yeung         
Sponsors and Collaborators
Stanford University
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Principal Investigator: Jennifer Ann Tremmel Stanford University
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Jennifer A Tremmel, MD, MS, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00823563    
Other Study ID Numbers: SU-01092009-1542
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022
Additional relevant MeSH terms:
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Chest Pain
Pathologic Processes
Neurologic Manifestations
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action