Status:
COMPLETED
Diagnostic Performance of Exercise Stress Tests for the Detection of Epicardial and Microvascular Coronary Artery Disease
Lead Sponsor:
Onze Lieve Vrouw Hospital
Collaborating Sponsors:
Centro Cardiologico Monzino
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Brief Summary
Prospective, single-arm, multicenter study of patients with an intermediate pre-test probability of CAD and positive exercise stress tests referred for invasive angiography. Patients underwent an inva...
Detailed Description
The Redefining the Diagnostic Performance of Non-invasive Tests for the Detection of Coronary Artery Disease: UZ Clear is an investigator-initiated, single-arm, multicenter, prospective study of patie...
Eligibility Criteria
Inclusion
- \- 1. Stable angina-like chest pain (typical or atypical) with intermediate (15-85%) pre-test probability of coronary artery disease using the ESC criteria.
- 2\. Positive non-invasive exercise test, or inconclusive stress with additional positive imaging.
Exclusion
- Age \<30 or \>80-year old
- Acute coronary syndromes.
- Known coronary artery disease
- Inability to perform exercise tests.
- Previous myocardial infarction.
- Previous CABG/PCI
- Left ventricular dysfunction EF \<35% or NYHA class III-IV
- Uncontrolled or recurrent ventricular tachycardia
- Atrial fibrillation
- Severe renal dysfunction, defined as an eGFR \<30 ml/min/1.73m2
- Contra-indication to adenosine (e.g. asthma bronchial, severe COPD)
- Active cancer
- Recent stroke
- Cardiomyopathy (dilated, hypertrophic, amyloidosis, arrhythmogenic right ventricular dysplasia)
- Left Bundle Branch Block or baseline ST-segment depression \>1mm.
- Congenital heart disease
- More than moderate valve disease
Key Trial Info
Start Date :
December 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05231161
Start Date
December 1 2019
End Date
December 31 2021
Last Update
February 9 2022
Active Locations (1)
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1
OLV Aalst
Aalst, Oost Vlanderen, Belgium, 9300