Women With Chest Pain and Normal Coronary Arteries Study

NCT00743197 | Terminated Results

• 1 other identifier: AB-08-002
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chest Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  1 year

Study Arms (2)

Usual Care Group

NO INTERVENTION

USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.

Medical Treatment Group

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; Drug: Lisinopril; Drug: Simvastatin; Drug: Lovaza; Behavioral: Therapeutic Lifestyle Changes

Interventions

Aspirin DRUG

Aspirin 81 mg daily

Medical Treatment Group

Lisinopril DRUG

Lisinopril 10 mg every night

Medical Treatment Group

Simvastatin DRUG

Simvastatin 20 mg every night

Also known as: Zocor

Medical Treatment Group

Lovaza DRUG

Lovaza 1 gram daily

Also known as: Fish Oil, Omega-3

Medical Treatment Group

Therapeutic Lifestyle Changes BEHAVIORAL

Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.

Medical Treatment Group

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Chest Pain; Coronary Artery Disease; Myocardial Ischemia

Interventions

Aspirin; Lisinopril; Simvastatin; Omacor; Fish Oils; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Oils; Lipids; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids

Limitations and Caveats

Study terminated due to departure of PI; all work including analyses ceased upon departure.In addition,study end points were based on changes b/w groups treatment vs. usual care) at 12 mo follow up- none of the subjects completed the Mo 12 visit.

Results Point of Contact

• Title: Dr. Martha Gulati, Principal Investigator
• Organization: Northwestern University

mgulati@nmh.org

312-695-4965

Study Officials

• Martha Gulati, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 12, 2023
• Results First Posted: November 23, 2011

Record last verified: 2023-11

Locations

US (1)