Sex Differences in Coronary Pathophysiology

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00823563
First received: January 14, 2009
Last updated: July 7, 2014
Last verified: July 2014
  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.


Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sex Differences in Symptomatic Non-Obstructive Coronary Disease: Do Women Have a Unique Coronary Pathophysiology?

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Sex Differences in Endothelial Dysfunction, Microvascular Dysfunction, and Diffuse Plaque [ Time Frame: Immediately ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular Outcomes [ Time Frame: 3 years and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: June 2007
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823563

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

Locations
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
Investigators
Principal Investigator: Jennifer Ann Tremmel Stanford University
  More Information

Additional Information:
Publications:
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00823563     History of Changes
Other Study ID Numbers: SU-01092009-1542
Study First Received: January 14, 2009
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chest Pain
Ischemia
Pain
Signs and Symptoms
Pathologic Processes
Adenosine
Nitroglycerin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 24, 2014