Women's Health Clinical Trials
Cedars-Sinai Heart Institute is currently conducting the following women's health clinical trials:
Low Estrogen Levels and Heart Disease in Premenopausal Women
Principal Investigator: C. Noel Bairey Merz, MD
IRB Approval Number: 6326
Contact: Jo-Ann Eastwood, PhD RN (310) 423-9680
Recruiting
Summary: Premenopausal women who have recently undergone a study of their coronary arteries will have their blood hormone levels measured over one menstrual cycle and correlated with coronary angiography results as well as an ultrasound of the carotid arteries. In addition, blood tests for cholesterol levels, blood sugar levels and other blood tests that have been shown to correlate with heart disease will be measured. This study also aims to evaluate a potential link between environmental stress and hormone levels. Patients will be asked to respond to questionnaires that evaluate stress, anxiety and depression and stress hormone (cortisol) levels in saliva will be measured. Blood samples will also be collected for genotyping and analysis of genes related to estrogen metabolism and future genotyping and analysis of cardiovascular genes.
Women's Health Research Registry
Principal Investigator: C. Noel Bairey Merz, MD
IRB Approval Number: 4269
Contact: Jana Williams (310) 423-9666
Recruiting
Summary: Women have been disproportionately underrepresented in clinical research. Few of the many drugs approved by the FDA have been adequately tested in women. The registry will allow qualified investigators to identify potential study participants and improve the quantity and quality of women able and willing to participate in trials. Investigators will utilize the Registry via the approved procedure of submitting an IRB approved protocol which will be reviewed by an Internal Review Committee. The protocol's inclusion/exclusion criteria will be used to query the database for eligible participants. The participants will be contacted by the Registry staff to ascertain their interest in this research protocol and their agreement to release their contact data to the investigator will be obtained. Women who are interested in participating in clinical trials are encouraged to join the registry. For more information about the Women's Health Research Registry or to register online, click here.
Coronary Microvascular Disease and Endothelial Function in Women
Principal Investigator: C. Noel Bairey Merz, MD
IRB Approval Number: 8221
Contact: Chrisandra Shufelt, MD (310) 423-9680
Recruiting
Summary: This study aims to specifically study a group of female patients who have chest pain or other signs or symptoms suggestive of heart disease but don't have visible blockages in the large heart arteries. Women with chest pain who undergo heart catheterization but have no blockages of large heart arteries will be consented and enrolled. They will be asked to fill out questionnaires about their medical history and undergo testing during heart catheterization that would test for abnormalities in their small heart arteries using acetylcholine and adenosine infusions. In addition they will be asked to undergo a non-invasive test called Peripheral Arterial Tonometry or PAT and in some cases, if indicated a Cardiac Magnetic Resonance (CMR) imaging test.
Small Artery Heart Disease in Women: Impact of Ranolazine
Principal Investigator: C. Noel Bairey Merz, MD
IRB Approval Number: 10465
Contact: Rosario D. Ando (310) 423-9666
Recruiting
Summary: The purpose of this study is to specifically study a group of female patients who have chest pain or other signs or symptoms suggestive of heart disease who have been diagnosed with microvascular disease of the heart by Cardiac Magnetic Resonance (CMR). The first part of the study is blinded and patients are randomized to receive either the ranolazine, a new medication for angina symptoms or a placebo. Study medication will be taken for 4 weeks (at 2 different doses) after which she will have a CMR and complete study questionnaires. This is followed by a 2 week washout period. Then the patient is given either extended release ranolazine or placebo depending on which she received the first time for a total of 4 weeks (at 2 different doses). This 4 week period will again be followed by a final CMR and questionnaire completion. Results from this study will help document the effects of ranolazine on patient symptoms and on blood flow to the heart as measured by CMR.
Cardiac Magnetic Resonance Imaging Normal Reference Control Group Testing - Ancillary Study to Coronary Endothelial Function and Microvascular Disease in Women
Principal Investigator: C. Noel Bairey merz, MD
IRB Approval Number: 11753
Contact: Rosario Ando (310) 423-9666
Recruiting
Summary: The purpose of this research is to understand how to apply cardiac magnetic resonance imaging (CMR) to women with small artery heart disease by looking at the CMRs of women without heart disease. In order to achieve this goal, 20 women between the ages 35-65 years with no known heart disease or heart disease risk factors will be recruited.
An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Women's Ischemia Symptom Questionnaire in Women with Chronic Angina Treated with Ranolazine Extended-release Tablets
Principal Investigator: C. Noel Bairey Merz, MD
IRB Approval Number: 12335
Contact: Margo Minissian, NP (310) 423-9680
Recruiting
Summary: The purpose of this study is to evaluate the validity, reliability and responsiveness of a new women's Ischemia symptom questionnaire (WISQ), which is designed to enhance the understanding and characterization of angina and responses to therapy specifically in women with chronic angina treated with Ranolazine following inadequate response to prior antianginals. In order to achieve this goal, 20 women aged 18 years or older who have at least three months of documented history of stable angina or anginal equivalents will be recruited. This study will be conducted in two phases, a qualifying evaluation phase (Phase I) and an open-label treatment phase (Phase II). Phase I will last approximately 2 weeks and include Visit 1 (Screening) and Visit 2 (Baseline). During this phase, subjects will continue to take their baseline antianginal medications without change to dose and/or frequency. Phase II will last approximately 4 weeks and include Visit 3 (Telephone Contact) and Visit 4 (Study Completion/Early Withdrawal). During this phase, subjects will be administered open-label Ranolazine ER 500mg (one tablet, twice a day, with or without food) and continue to take their baseline antianginal medications. Subjects will have a follow-up telephone contact approximately 1 week after the Study Completion visit.
A Double-Blind, Multicenter, Placebo Controlled Study of Aldosterone Blockade (Eplerenone) in Women with Chest Pain, Coronary Vascular Dysfunction and Evidence of Myocardial Ischemia in the Absence of Significant Epicardial Coronary Artery Disease (EWISE)
Principal Investigator: C. Noel Bairey Merz, MD
IRB Approval Number: 11727
Contact: Chrisandra Shufelt, MD (310) 423-9680
Recruiting
Summary: The purpose of this research is to determine if treatment with the medication Eplerenone can improve the function of these microvascular blood vessels, and possibly, improve the chest pain. In order to achieve this goal, 6 women between the ages 21-75 years with heart disease will be recruited. Study subjects have five clinic visits (screening, week 1, week 4, week 8 and week 16) during a 16-week period and long-term annual follow-up visits. The procedures to be performed include physical exams, blood tests, heart angiogram, pulse wave velocity (not at Cedars Study Site), exercise treadmill, study drug administration and questionnaires.
