Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction
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|ClinicalTrials.gov Identifier: NCT00832702|
Recruitment Status : Active, not recruiting
First Posted : January 30, 2009
Last Update Posted : June 15, 2018
This research study is designed to investigate the approaches to 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. Two study sites (Cedars-Sinai Medical Center and University of Florida) are recruiting participants.
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 their at least 1-year followup visit.
Patients will be followed up using phone questionnaires at 6 weeks, 6 months for 5 years, and than annually for 20 years 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 or disease||Intervention/treatment|
|Cardiovascular Disease||Procedure: Cardiac MRI|
|Study Type :||Observational|
|Estimated Enrollment :||433 participants|
|Official Title:||Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction|
|Actual Study Start Date :||September 17, 2008|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2020|
- Procedure: Cardiac MRI
CMRI provides unique clinical utilities including excellent soft tissue characterization and contrast, three-dimensionality, quantitation of blood flow, and overall superior temporal and spatial resolution to image vascular and myocardial abnormalities.
- Abnormal cardiac magnetic resonance imaging (CMRI) [ Time Frame: 1 year ]Subjects will be contacted at 1-year followup.
- Resource utilization and costs [ Time Frame: up to 20 years ]Annual costs will include cardiovascular hospitalizations, coronary revascularizations and angiography, outpatient testing, and visits to generalists, specialists, nurse practitioners/ physician's assistants, or community clinics.
- Persistent Chest Pain Symptoms [ Time Frame: up to 20 years ]Detailed information on chest pain symptoms will include the traditional angina questionnaire and the WISE female angina questionnaire
- Quality of Life Outcomes [ Time Frame: up to 20 years ]Quality of life and functional capacity will be collected using the standard instruments of SAQ and DASI
Biospecimen Retention: Samples With DNA
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): NCT00832702
|United States, California|
|Cedars-Sinai Barbra Streisand Women's Heart Center|
|Los Angeles, California, United States, 90048|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610-0277|
|Principal Investigator:||C. Noel Bairey Merz, MD, FACC||Cedars-Sinai Medical Center|
|Principal Investigator:||Carl J Pepine, MD, MACC||University of Florida|