Women With Chest Pain and Normal Coronary Arteries Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00743197|
Recruitment Status : Terminated (Terminated due to departure of PI from institution.)
First Posted : August 28, 2008
Results First Posted : November 23, 2011
Last Update Posted : December 5, 2011
The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain, coronary endothelial dysfunction and unblocked coronary arteries.
Coronary endothelial dysfunction (CED) is a condition in which the layers of cells around the heart do not function properly and is believed to be key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for future cardiovascular events, such as heart attack and stroke.
A coronary angiogram allows physicians to see if any of the arteries in the heart are blocked, usually by fatty plaque. In many instances, angiograms in women experiencing chest pain do not show evidence of coronary disease (free of significant plaque build-up). Currently, there is no standard of care treatment plan for patients with normal coronary arteries, despite symptoms of chest pain, and as a result these patients may not receive medical treatment. However, these women often return to their physicians more than once with chest pain and go through a similar battery of tests.
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain||Drug: Aspirin Drug: Lisinopril Drug: Simvastatin Drug: Lovaza Behavioral: Therapeutic Lifestyle Changes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Women With Chest Pain and Normal Coronary Arteries Study: A Randomized Study of Medical Treatment and Therapeutic Lifestyle Changes|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
No Intervention: Usual Care Group
USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
Active Comparator: Medical Treatment Group
TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
Aspirin 81 mg dailyDrug: Lisinopril
Lisinopril 10 mg every nightDrug: Simvastatin
Simvastatin 20 mg every night
Other Name: ZocorDrug: Lovaza
Lovaza 1 gram daily
Other Name: Fish Oil, Omega-3Behavioral: Therapeutic Lifestyle Changes
Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.
- Effectiveness of Therapy Compared to Usual Care, in Those Women With Chest Pain (CP), Reversible Ischemia by Stress Testing and Nonobstructive Coronary Artery Disease (CAD) by Angiography Who Are Found to Have Coronary Endothelial Dysfunction (CED). [ Time Frame: 1 year ]The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain (CP), coronary endothelial dysfunction (CED) and unblocked coronary arteries. CED is a condition in which the layers of cells around the heart do not function properly and is believed to be a key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for suture cardiovascular events, such as heart attack and stroke.
- The Role and Function of Endothelial Progenitor Cells (EPCs) in the Presence of Proven Endothelial Dysfunction and the Response of EPCs to Medical Therapy for Endothelial Dysfunction. [ Time Frame: 1 year ]no analyses were conducted due to the PI's departure from the institution; all work including analyses ceased upon departure- the study was not transferred with the PI. In addition, the study end points were based on changes between groups (treatment vs. usual care group) at 12 month follow up for both groups - none of the enrolled subjects made it to the final (month 12) visit.
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): NCT00743197
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Martha Gulati, MD||Northwestern University|