Chest Pain
Conditions
Keywords
coronary artery disease (CAD), chest pain, myocardial ischemia, endothelial function
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.
Interventions
DRUGAspirin
Aspirin 81 mg daily
DRUGLisinopril
Lisinopril 10 mg every night
DRUGSimvastatin
Simvastatin 20 mg every night
DRUGLovaza
Lovaza 1 gram daily
BEHAVIORALTherapeutic Lifestyle Changes
Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.
Sponsors
Astellas Pharma US, Inc.
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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. | 2 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated due to departure of PI. | 1 | 2 |
Baseline characteristics
| Characteristic | Usual Care Group | Medical Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
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.
Time frame: 1 year
Population: 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.
Comparison: 0