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Women With Chest Pain and Normal Coronary Arteries Study

Primary Purpose

Chest Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Lisinopril
Simvastatin
Lovaza
Therapeutic Lifestyle Changes
Sponsored by
Anna Huskin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chest Pain focused on measuring coronary artery disease (CAD), chest pain, myocardial ischemia, endothelial function

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care Group

Medical Treatment Group

Arm Description

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

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.

Outcomes

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).
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.
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.

Full Information

First Posted
August 26, 2008
Last Updated
March 2, 2022
Sponsor
Anna Huskin
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00743197
Brief Title
Women With Chest Pain and Normal Coronary Arteries Study
Official Title
Women With Chest Pain and Normal Coronary Arteries Study: A Randomized Study of Medical Treatment and Therapeutic Lifestyle Changes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to departure of PI from institution.
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Huskin
Collaborators
Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
coronary artery disease (CAD), chest pain, myocardial ischemia, endothelial function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
Arm Title
Medical Treatment Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 81 mg daily
Intervention Type
Drug
Intervention Name(s)
Lisinopril
Intervention Description
Lisinopril 10 mg every night
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
Simvastatin 20 mg every night
Intervention Type
Drug
Intervention Name(s)
Lovaza
Other Intervention Name(s)
Fish Oil, Omega-3
Intervention Description
Lovaza 1 gram daily
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Lifestyle Changes
Intervention Description
Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Gulati, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Women With Chest Pain and Normal Coronary Arteries Study

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