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Sponsors and Collaborators: |
Cedars-Sinai Medical Center National Institutes of Health (NIH) |
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Information provided by: | Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT00832702 |
This research study is designed to investigate the approaches to the noninvasive detection and assessment of coronary vascular dysfunction in women by comparing the testing results from the invasive standard care diagnostic procedure Angiogram and from the additional noninvasive diagnostic procedure CMR Imaging. The investigators want to specifically study 375 female patients who have signs or symptoms suggestive of heart disease but don't have obstructive coronary artery disease.
The standard of care procedures include demographics, review of recent clinical symptoms, review of medications being taken, a physical exam, pre-angiogram blood collection, chest x-ray, ECG and heart angiogram. The research procedures for this study are the cold pressor testing, blood/urine collection, health questionnaire, the post-angiogram ECG and cardiac MRI.
Patients will be asked to undergo heart angiogram testing to test for abnormalities in their heart arteries. If the heart angiogram shows that the patients do not have blockages in major heart arteries, then the patients will have coronary flow reserve measurement test (as part of the heart angiogram) to determine whether the patients have abnormally functioning of the small heart arteries. This test will be performed by infusing the three drugs: adenosine, acetylcholine and nitroglycerin. The three drugs are naturally occurring substances and have been used for routine heart angiograms.
Cardiac Magnetic Resonance (CMR) imaging may help us more easily and non-invasively detect abnormalities in the inner layer of the heart muscle resulting from the abnormal function of the heart arteries. All the 375 participants will undergo baseline CMR imaging test and a subgroup of 200 participants will undergo a second CMR imaging test at 1-year followup visit.
Patients will be followed up using phone questionnaires at 6 weeks, 6 months and than annually thereafter. Other procedures in this study include obtaining informed consent, review of demographics, physical examination, ECG, blood and urine tests, clinical symptoms, medications, questionnaires, etc. The core laboratories include Blood, Lipoprotein, Chemistry Core Lab, Reproductive Hormone Core Lab, Inflammatory Marker Core Lab, Oxidative Stress Core Lab, and Angiographic Core Lab. Additionally, GCRC at Cedars Sinai will process, store and ship samples as needed/required.
Condition | Intervention | Phase |
---|---|---|
Coronary Vascular Dysfunction |
Procedure: Cardiac MRI |
Phase III |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction |
Blood sample will be collected for future genetic studies to better understand heart artery disease by identifing genetic factors that contribute to heart artery disorders, and for extraction and creation of cell lines.
Estimated Enrollment: | 375 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
See the Brief Summary above.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women undergoing clinically-ordered coronary angiography for suspected ischemia will be recruited.See the inclusion and exclusion criteria for details.
Inclusion Criteria:
Exclusion Criteria:
Contact: Rosario Ando | 3104239666 | rosario.ando@cshs.org |
Contact: Ying Mou, MEd | 3104239678 | ying.mou@cshs.org |
United States, California | |
Cedars-Sinai Medical Center Women's Heart Center / PRCC | Recruiting |
Los Angeles, California, United States, 90048 | |
Contact: Ying Mou, MEd 310-423-9678 | |
Contact: Rosario Ando 3104239666 | |
Principal Investigator: C. Noel Bairey Merz, MD |
Principal Investigator: | C. Noel Bairey Merz, MD | Cedars-Sinai Medical Center |
Responsible Party: | Cedars-Sinai Medical Center ( C. Noel Bairey Merz, MD ) |
Study ID Numbers: | IRB# 14906 |
Study First Received: | January 28, 2009 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00832702 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cardiac MRI |
Ischemia |