Women's Health Clinical Trials

Cedars-Sinai Heart Institute is currently conducting the following women's health clinical trials:

 

Effects of Traditional Acupuncture on Mechanisms of CHD

Principal Investigator: C. Noel Bairey Merz, MD

IRB Approval Number: 7320

Contact: Rosario Ando (310) 423-9666

Status: Completed

Summary: The purpose of this study is to determine whether complementary medicine practice of traditional acupuncture versus an alternative intervention can serve as an additive/alternative treatment for the prevention of acute cardiac events in coronary heart disease patients. It will also investigate 1) arterial vasomotor dysfunction (ability of the brachial artery to expand under stress); 2) autonomic nervous system imbalance (measure beat-to-beat time variations of the heart); and the secondary outcomes of; 3) inflammatory marker (high-sensitivity C reactive protein) and; 4) psychological stress and quality of life. Patients with coronary artery disease as evidenced by a history of coronary artery bypass graft, percutaneous coronary intervention, stroke and angiographic evidence of coronary artery stenosis in at least one coronary artery are eligible to participate. 


WISE Coronary Vascular Disease

Principal Investigator: C. Noel Bairey Merz, MD

IRB Approval Number: 14906

Contact: Rosario Ando (310) 423-9666

Status: Enrolling

Summary: The purpose of this study is 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 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.


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 (310) 423-9680

Status: Temporarily not enrolling

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: Shivani Dhawan (310) 423-9744

Status: Enrolling

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.


Coronary Microvascular Disease and Endothelial Function in Women

Principal Investigator: C. Noel Bairey Merz MD

IRB Approval Number: 8221

Contact:  Puja Mehta, MD (310) 423-9680

Status: Enrolling

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

Status: Enrollment closed.

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 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

Status: Enrolling

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

Status: Enrolling

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.


Advanced Magnetic Resonance Imaging in Women with Ischemic Heart Disease

Principal Investigator:  Louis Thomson, MD    

IRB Approval Number: 17134

Contact:  Rosario Ando, MD (310) 423-9666

Status: Enrolling

Summary: The purpose of the proposed analysis is to improve microvascular dysfunction noninvasively in patients with known or suspected impaired coronary flow reserve and subclinical diastolic dysfunction. This study will utilize new MRI software currently on the market to more precisely analyze images of the heart for blood flow and blood flow dysfunction in and out of the heart in different areas (chambers) of the heart. The new CAAS MRV (Magnetic Resonance Ventricular analysis) software enables cardiologists and radiologists to perform functional analysis on cine-magnetic resonance images for cardiac MRI studies. The quantitative analysis package provides automatic segmentation of the endo- and epicardial left ventricular heart wall on all short axis images, both in time and space. This research project will utilize existing and future Image data from currently IRB approved research (IRB#s: 10465, 11753 and 14906). Data is in dicom format and is coded. Dicom stands for "Digital Imagine and Communications in Medicine" and is a standard for handling, storing, printing, and transmitting information in medical imaging.


Pilot Study - The Impact of Traditional Acupuncture on Menopausal Vasomotor Symptoms, Psychological Stress and the Hypothalamic Pituitary Adrenal (HPA) – Sympathetic Nervous System (SNS) Axis: A Randomized, Controlled Trial

Principal Investigator: C. Noel Bairey Merz, MD    

IRB Approval Number: 16997

Contact: Jeannette Painovich (310) 423-9666

Status: Follow-up

Summary: The purpose of this study is to examine the effects of acupuncture on menopausal symptoms. We will recruit 60 Cedars employees (excluding Dr Bairey Merz's employees) with menopausal symptoms by posting a study flyer on Exchange. This pilot project will collect data from three study groups. The first research study group will undergo traditional acupuncture (TA). The second research study group will receive alternative acupuncture (AA). The third group will be a waiting control group (WC) that will receive four weeks of acupuncture following completion of the study duration.


Cortisol levels on Menopausal Vasomotor Symptoms - an Ancillary (Addendum) Study to the "Impact of Traditional Acupuncture on Menopausal Vasomotor Symptoms, Psychological Stress and the Hypothalamic Pituitary Adrenal (HPA) – Sympathetic Nervous System (SNS) Axis: A Randomized, Controlled Trial"

Prinicipal Investigator: Chrisandra Shufelt, MD    

IRB Approval Number: 17569

Contact: Chrisandra Shufelt, MD (310) 423-9660

Status: Enrolling

Summary: This is an ancillary study to Protocol 16997 to examine the stress hormone level in women with menopausal symptoms. This ancillary project will collect additional data from the 60 subjects enrolled in Protocol 16997. This study protocol will include an ACTH (Hormone) Stimulation Test which will assess the functioning of stress response in the subjects at entry and exit. Subjects will undergo the ACTH test for this ancillary protocol in the morning when they complete 24-hour urine collection for Protocol 16997. A total of 50mL of blood will be drawn to test serum blood hormone levels from the subjects during the ACTH (Hormone) Stimulation Test.


Variation in Recovery: Role of Gender on Outcomes in Acute Myocardial Infarction (AMI) Patients (VIRGO)

Principal Investigator: C. Noel Bairey Merz, MD      

IRB Approval Number: 16031

Contact: Margo Minissian, NP (310) 423-9680

Status: Enrolling

Summary: This is a research study of men and women who are 55 years of age or younger, who have had heart attacks. A total of 3,000 men and women will be enrolled in this study from approximately 120 different hospitals across the country. This study is designed to better understand the recovery period by examining certain things that can influence recovery from a heart attack. Some of these things include heart attack symptoms (chest pain or angina, shortness of breath), daily functioning, and important relationships in patients’ life. By collecting this information, including how patients are currently doing, medical history and the treatments patients received in the hospital, researchers can try to understand how these things affect recovery from a heart attack, and if they influence recovery differently for men and women. The purposes of the study are to determine sex differences in outcomes following AMI, to determine sex differences in the prevalence and prognostic importance of demographic, clinical, and psychosocial risk factors, to determine sex differences in quality of care, and to determine sex differences in the prevalence and prognostic importance of selected biochemical biomarkers following AMI.


Effects of Alternative dosing of Rosuvastatin, Atorvastatin and Simvastatin in Patients with Statin Intolerance to Daily Dosing

Principal Investigator: C. Noel Bairey Merz, MD

IRB Approval Number: 19454

Contact: Margo Minissian, NP (310) 423-9680

Status: Enrolling

Summary: The aim of this study is to evaluate the effectiveness of Rosuvastatin, Atorvastatin and Simvastatin in patients with prior statin intolerance using alternative dosing for the reduction of low-density lipoprotein (LDL-C). The purpose is to show clinical relevancy in alternative dosing of statins in an attempt to reduce adverse events and thus to increase patient compliance.


Long Term Effects of the Transcendental Meditation Program on Mortality in Patients with Documented Coronary Heart Disease and CHD Risk Factors

Principal Investigator: C. Noel Bairey Merz, MD     

IRB Approval Number: 14658

Contact: Rosario Ando (310) 423-9666

Status: Completed

Summary: The purpose of this study is to evaluate the long-term effects of meditation practice on all-cause and cardiovascular mortality rates in patients with documented coronary heart disease (CHD) and CHD risk factors using a followup search from the National Death Index (US Dept. of Health and Human Services) database. The objective of this followup study is to confirm the preliminary study findings using a substantially larger sample size from a larger number of separate clinical trials and to enhance generalizability of the findings with more diverse ethnic and racial populations.


WISE Ancillary Study Data Analyses: Efficacy of Hormone Replacement on Myocardial Ischemia in Postmenopausal Women with Normal/Minimal Coronary Artery Disease

Principal Investigator: C. Noel Bairey Merz, MD         

IRB Approval Number: 9260

Contact: Shivani Dhawan (310) 423-9680

Status: Data Analysis

Summary: The purpose of this study was to evaluate the effect of estrogen replacement therapy with FemHRT in postmenopausal women with decreased blood supply to the heart muscle even when they have normal coronary arteries compared to men.


The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels in Healthy Premenopausal Women

Principal Investigator: Glenn Braunstein, MD

IRB Approval Number: 6110

Contact: YuChing Yang (310) 423-9666

Status: Data Analysis

Summary: The purpose of this study is to test whether red and/or white wine has an effect on circulating estrogen and progesterone levels in the blood.


Reproductive Hormones and Pre-clinical CVD in Women

Principal Investigator: C. Noel Bairey Merz, MD     

IRB Approval Number: 4260

Contact: YuChing Yang (310) 423-9666

Status: Data Analysis

Summary: The purpose of this study is to investigate markers of heart disease in healthy women and compare this to their natural hormone levels to better understand the role of hormones and heart disease.


Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women

Principal Investigator: C. Noel Bairey Merz, MD

IRB Approval Number: 3954

Contact:  YuChing Yang (310) 423-9666

Status: Data Analysis

Summary: Several risk factors including high cholesterol contribute to heart disease. The purpose of this study is to investigate the effect of lowering triglycerides and raising HDL (protective cholesterol) in reducing the risk for heart disease in women and to see improvement in markers of inflammation and clot formation and blood vessel health.


Androgens, insulin resistance and risk of cardiovascular disease in women: WISE Ancillary Androgen Study

Principal Investigator: C. Noel Bairey Merz, MD

IRB Approval Number: 3858

Contact: YuChing Yang (310) 423-9666

Status: Data Analysis

Summary: The purpose of this study is to use existing blood specimens to measure androgen level to better understand the complex relationship between hormone interactions and cardiovascular disease (CVD).


Women’s Ischemic Symptom Evaluation – Blood Hormone Level Determination

Principal Investigator: C. Noel Bairey Merz, MD      

IRB Approval Number: 2398

Contact: YuChing Yang (310) 423-9666

Status: Data Analysis

Summary: The purpose of this study is to develop improved heart disease detection techniques in women, to improve understanding of the role arterial function plays in heart disease in women, and to explore the influence of hormones on heart disease in women.