Women With Chest Pain and Normal Coronary Arteries Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
Drug: Lovaza
Lovaza 1 gram daily
Other Names:
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.
|
Outcome Measures
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). [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. [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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Anna Huskin
- Astellas Pharma US, Inc.
Investigators
- Principal Investigator: Martha Gulati, MD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AB-08-002
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Usual Care Group | Medical Treatment Group |
|---|---|---|
| Arm/Group 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. |
| Period Title: Overall Study | ||
| STARTED | 1 | 2 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Usual Care Group | Medical Treatment Group | Total |
|---|---|---|---|
| Arm/Group 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. | Total of all reporting groups |
| Overall Participants | 1 | 2 | 3 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
1
100%
|
2
100%
|
3
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
100%
|
2
100%
|
3
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
1
100%
|
2
100%
|
3
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| no analyses were conducted due to PI's departure from institution;all work including analyses ceased upon departure-the study was not transferred with the PI. In addition, study end points were based on changes between groups (treatment vs. usual care)at 12-mo follow up for both groups- none of the enrolled subjects completed the month 12 visit. |
| Arm/Group Title | Usual Care Group | Medical Treatment Group |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 0 | 0 |
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Usual Care Group, Medical Treatment Group |
|---|---|---|
| Comments | 0 | |
| Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
| Comments | 0 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Other |
| Estimated Value | 0 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 0 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Usual Care Group | Medical Treatment Group | ||
| Arm/Group 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. | ||
All Cause Mortality |
||||
| Usual Care Group | Medical Treatment Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Usual Care Group | Medical Treatment Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/2 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Usual Care Group | Medical Treatment Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/2 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Martha Gulati, Principal Investigator |
|---|---|
| Organization | Northwestern University |
| Phone | 312-695-4965 |
| mgulati@nmh.org |
- AB-08-002