Marcia L. Stefanick, Ph.D.
Sex Differences in Coronary Pathophysiology
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- 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
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1) Patient referred for elective coronary angiography becuase 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).
Key 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)
Additional Study Details
Official Title:
Sex Differences in Symptomatic Non-Obstructive Coronary Disease: Do Women Have a Unique Coronary Pathophysiology?Anticipated start date:
6/5/2007Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
ObservationalPurpose:
NOTNEEDEDDuration:
Cross-sectionalSelection:
Convenience SampleTiming:
ProspectiveTotal Number to be Enrolled:
126Total Number to be Enrolled at Stanford:
126More Information
Publications About this Study:
- 17603424: Ischemic heart disease in women: an appropriate time to discriminate.
- 17405972: Postmenopausal hormone therapy and risk of cardiovascular disease by age and years since menopause.
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/23/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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