Trials / Withdrawn
WithdrawnNCT02313987
Endothelial Function-guided Therapy Compared to Usual Care in Patients With NOCAD
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
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Itamar-Medical, Israel · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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).
Conditions
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2018-06-01
- Completion
- 2018-12-01
- First posted
- 2014-12-10
- Last updated
- 2016-02-24
Locations
2 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT02313987. Inclusion in this directory is not an endorsement.