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The current study is designed to test the hypothesis that compared to conventional treatment; endothelial function-guided treatment reduces adverse cardiovascular events in patients with non-obstructive coronary artery disease documented at clinically indicated coronary angiography.
Subjects with chest pain and non-obstructive coronary artery disease (20-70% luminal diameter narrowing) documented by coronary angiograms will be enrolled in the study 2 - 30 days following the coronary angiograms. Only subjects who have signed an Informed Consent Form and meet all of the eligibility criteria will be qualified for enrollment.
Following the baseline EndoPAT testing subjects will be divided into two groups by their EndoPAT (EndoScore) results:
Staff prescribing treatment regime for subjects in group A and B1 ("usual care") along with the subjects in these groups, will be blinded to the EndoScore value.
Subjects of all groups will return for 4 follow-up visits: 180±14days, 360±14days, 720±14days and 1080±14days (study end).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-Usual care- Standard care for NOCAD | Subjects with non obstructive CAD (20-70% luminal diameter stenosis) and normal Endothelial function as defined by EndoScore. These subjects will receive the standard care usually provided in each facility for patients with NOCAD | ||
| B1-Usual Care-Standard care for NOCAD | Subjects with non obstructive CAD (20-70% luminal diameter stenosis ) and abnormal Endothelial function as defined by EndoScore. These subjects will receive the standard care usually provided in each facility for patients with NOCAD. (Same care as Group A) | ||
| B2- Endothelial function guid care | Subjects with non obstructive CAD and abnormal Endothelial function as defined by EndoScore. These subjects will receive the an Endothelial Function-guided Therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| MACE | Time to the first occurrence of death, cardiovascular death, non-fatal myocardial infarction, stroke, transient ischemic attack, coronary revascularization, or hospitalization for congestive heart failure. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalization for chest pain | 3 years | |
| quality of life questionnaire | 3years | |
| time to the first occurrence of cardiovascular death |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with chest pain and non-obstructive coronary artery disease (20-70% diameter luminal narrowing) will be enrolled in the study 2-30 days following the coronary angiograms
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| Name | Affiliation | Role |
|---|---|---|
| Amir Lerman, M.D; Prof | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Hospital | Kfar Saba | Israel | ||||
| Tel Hashomer |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 3 years |
| myocardial infarction | 3 years |
| Stroke | 3 years |
| time to the first occurrence of death from any cause | 3 years |
| hospitalization for worsening heart failure | 3 years |
| time to the first occurrence of ischemic fatal or non-fatal stroke or transient ischemic attack. | 3 years |
| Ramat Gan |
| 52621 |
| Israel |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |