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Women With Chest Pain and Normal Coronary Arteries Study

This study has been terminated.
(Terminated due to departure of PI from institution.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743197
First Posted: August 28, 2008
Last Update Posted: December 5, 2011
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.
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Anna Huskin, Northwestern University
  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: None (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:


Further study details as provided by Anna Huskin, 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 ]
    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 ]
    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
Drug: Lisinopril
Lisinopril 10 mg every night
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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


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

Responsible Party: Anna Huskin, Clinical Design Manager, Northwestern University
ClinicalTrials.gov Identifier: NCT00743197     History of Changes
Other Study ID Numbers: AB-08-002
First Submitted: August 26, 2008
First Posted: August 28, 2008
Results First Submitted: September 13, 2011
Results First Posted: November 23, 2011
Last Update Posted: December 5, 2011
Last Verified: November 2011

Keywords provided by Anna Huskin, Northwestern University:
coronary artery disease (CAD)
chest pain
myocardial ischemia
endothelial function

Additional relevant MeSH terms:
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aspirin
Simvastatin
Lisinopril
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors