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: 1. Group A - normal EndoScore: Logarithmic value of RHI (Ln\_RHI) \>0.7 2. Group B - abnormal EndoScore: Ln\_RHI ≤ 0.7 The subjects of Group B will be randomized in 1:1 ratio (by envelopes with randomization numbers at each site) to Group B1 who will be treated conventionally i.e., "usual care" by the site study team; and Group B2 who will be treated with "enhanced care". 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).
Study Type
OBSERVATIONAL
Meir Hospital
Kfar Saba, Israel
Tel Hashomer
Ramat Gan, Israel
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.
Time frame: 3 years
Rehospitalization for chest pain
Time frame: 3 years
quality of life questionnaire
Time frame: 3years
time to the first occurrence of cardiovascular death
Time frame: 3 years
myocardial infarction
Time frame: 3 years
Stroke
Time frame: 3 years
time to the first occurrence of death from any cause
Time frame: 3 years
hospitalization for worsening heart failure
Time frame: 3 years
time to the first occurrence of ischemic fatal or non-fatal stroke or transient ischemic attack.
Time frame: 3 years
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