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

Sponsor:	Northwestern University
Collaborator:	Astellas Pharma US, Inc.
Information provided by:	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, lisinopril, simvastatin, lovaza

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment
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

Drug Information available for: Acetylsalicylic acid Simvastatin Lisinopril Omacor

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Assess effectiveness of therapy compared to usual care, in those women with CP, reversible ischemia by stress testing and nonobstructive CAD by angiography who are found to have coronary endothelial dysfunction. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess 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 ]

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
2: Active Comparator 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, lisinopril, simvastatin, lovaza Aspirin 81 mg daily,lisinopril 10 mg every night, simvastatin 20 mg every night, fish oil (Lovaza 1 gram daily). Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.

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 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 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 PTCA/stent or CABG
Contraindications to MRI
Cardiac catheterization for valvular disease
Cardiac catheterization for heart failure assessment/biopsy
Known CHF/HOCM/DCM;
Acute Renal Failure
Chronic renal failure (eGFR <30 ml/min/1.73m2) 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 AV block)

Contacts and Locations

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

Contacts

Contact: Amy Miller, RN

312-695-2734

ammiller@nmh.org

Locations

United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Byron Yip 312-695-3270 b-yip@northwestern.edu
Sub-Investigator: Neil Stone, MD
Sub-Investigator: Doug Losordo, MD
Sub-Investigator: Charles Davidson, MD
Sub-Investigator: Richard Lee, MD
Sub-Investigator: Robert Bonow, MD

Sponsors and Collaborators

Northwestern University

Astellas Pharma US, Inc.

Investigators

Principal Investigator:

Martha Gulati, MD

Northwestern University

More Information

No publications provided

Responsible Party:	Northwestern University ( Martha Gulati, M.D. )
Study ID Numbers:	AB-08-002
Study First Received:	August 26, 2008
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00743197 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

CAD
chest pain
myocardial ischemia
endothelial function

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Hematologic Agents
Pain
Fibrinolytic Agents
Signs and Symptoms
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Simvastatin
Antilipemic Agents
Lisinopril
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Chest Pain
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on February 08, 2010