An interventional study of Aspirin and Lisinopril in Chest Pain, sponsored by Northwestern University. Terminated at 1 site in United States. Open to female participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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.
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.
388 studies on the registry are indexed under Chest Pain; 67 are open to participants now.
This study's enrollment of 3 is below the median of 147 across 204 interventional studies indexed under Chest Pain.
Browse Chest Pain studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.
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Exclusion Criteria:
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.
Drug: Aspirin · Drug: Lisinopril · Drug: Simvastatin · Drug: Lovaza · Behavioral: Therapeutic Lifestyle Changes
Aspirin 81 mg daily
Lisinopril 10 mg every night
Simvastatin 20 mg every night
Also known as: Zocor
Lovaza 1 gram daily
Also known as: Fish Oil, Omega-3
Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.
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
| Milestone | Usual Care Group | Medical Treatment Group |
|---|---|---|
| Started | 1 | 2 |
| Completed | 0 | 0 |
| Not completed | 1 | 2 |
| Withdrew: Study terminated due to departure of pi. | 1 | 2 |
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care Group | — | 0/1 (0%) | 0/1 (0%) |
| Medical Treatment Group | — | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Usual Care Group | Medical Treatment Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 2 | 3 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Usual Care Group | Medical Treatment Group | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Usual Care Group | Medical Treatment Group | Total |
|---|---|---|---|
| United States | 1 | 2 | 3 |
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Aspirin · Lisinopril · Simvastatin · Omacor