Women With Chest Pain and Normal Coronary Arteries Study - Full Text View

Sponsor:	Anna Huskin
Collaborator:	Astellas Pharma US, Inc.
Information provided by (Responsible Party):	Anna Huskin, Northwestern University
ClinicalTrials.gov Identifier:	NCT00743197

Purpose

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	Intervention
Chest Pain	Drug: Aspirin Drug: Lisinopril Drug: Simvastatin Drug: Lovaza Behavioral: Therapeutic Lifestyle Changes

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Women With Chest Pain and Normal Coronary Arteries Study: A Randomized Study of Medical Treatment and Therapeutic Lifestyle Changes

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain Coronary Artery Disease

Drug Information available for: Acetylsalicylic acid Simvastatin Lisinopril Omacor

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

Enrollment:	3
Study Start Date:	May 2008
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: Aspirin Aspirin 81 mg daily Other Name: Aspirin Drug: Lisinopril Lisinopril 10 mg every night Other Name: Lisinopril Drug: Simvastatin Simvastatin 20 mg every night Other Name: Zocor Drug: Lovaza Lovaza 1 gram daily Other Name: Fish Oil, Omega-3 Behavioral: 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. Other Name: Therapeutic Lifestyle Changes

Arms

Assigned Interventions

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.

Drug: Aspirin

Aspirin 81 mg daily

Other Name: Aspirin

Drug: Lisinopril

Lisinopril 10 mg every night

Other Name: Lisinopril

Drug: Simvastatin

Simvastatin 20 mg every night

Other Name: Zocor

Drug: Lovaza

Lovaza 1 gram daily

Other Name: Fish Oil, Omega-3

Behavioral: 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.

Other Name: Therapeutic Lifestyle Changes

Detailed Description:

Endothelial function testing will be performed on women without significant coronary disease in order to help identify women who may be likely to develop coronary artery disease (CAD) and who would benefit from aggressive lifestyle (dietary counseling, exercise) or medical (treatment with aspirin and cholesterol and blood pressure lowering medications) interventions.

Eligibility

Ages Eligible for Study:	30 Years to 90 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female gender
Age 30 or greater
Present with symptoms suggestive of Angina (Typical or "Atypical")
Abnormal myocardial perfusion scan
Referred for angiography
Normal (0% stenosis) versus Nonobstructive coronary artery disease (CAD) (<50% stenosis)
Evidence of endothelial dysfunction.

Exclusion Criteria:

Coronary vasospasm known or documented in cardiac catheterization
Obstructive CAD (greater than 50% stenosis) known or documented in cardiac catheterization
Pregnancy
Established CAD, history of revascularization with percutaneous transluminal coronary angioplasty (PTCA)/stent or coronary artery bypass graft (CABG)
Contraindications to magnetic resonance imaging (MRI)
Cardiac catheterization for valvular disease
Cardiac catheterization for heart failure assessment/biopsy
Known congestive heart failure (CHF)/hypertrophic obstructive cardiomyopathy (HOCM)/dilated cardiomyopathy (DCM)
Acute Renal Failure
Chronic renal failure (estimated glomerular filtration rare (eGFR) <30 ml/min/1.73m^2) or on hemodialysis
Known single kidney
History of peptic ulcer disease, known gastrointestinal bleed, known contraindication to aspirin
Known contraindication to statin
Known contraindication to adenosine (asthma, high degree atrial ventricular (AV) block)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743197

Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Anna Huskin

Astellas Pharma US, Inc.

Investigators

Principal Investigator:

Martha Gulati, MD

Northwestern University

More Information

No publications provided

Responsible Party:	Anna Huskin, Clinical Design Manager, Northwestern University
ClinicalTrials.gov Identifier:	NCT00743197 History of Changes
Other Study ID Numbers:	AB-08-002
Study First Received:	August 26, 2008
Results First Received:	September 13, 2011
Last Updated:	November 30, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

coronary artery disease (CAD)
chest pain
myocardial ischemia
endothelial function

Additional relevant MeSH terms:

Chest Pain
Pain
Signs and Symptoms
Aspirin
Lisinopril
Simvastatin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents
Cardiotonic Agents

ClinicalTrials.gov processed this record on February 09, 2012