Coronary Atherosclerosis Clinical Trial
Official title:
The Impact of Endothelial Function-guided Therapy Compared to Usual Care on Major Adverse Cardiovascular Events in Patients With Chest Pain and Non-obstructive Coronary Artery Disease
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).
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Observational Model: Case Control, Time Perspective: Prospective
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