NCT05231161

Diagnostic Performance of Exercise Stress Tests for the Detection of Epicardial and Microvascular Coronary Artery Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 114 (actual)
• Sponsor: Onze Lieve Vrouw Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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 invasive diagnostic procedure (IDP) with measurement of fractional flow reserve (FFR) and index of microvascular resistance (IMR) in at least one coronary vessel. The objective was to determine the false discovery rate (FDR) of cardiac exercise stress tests with both FFR and IMR as references.

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 patients presenting with chest pain with an intermediate probability of CAD. The intermediate pre-test probability of CAD was defined based on the European Society of Cardiology Guidelines as a score between 15% and 85% based on age, sex, and the nature of symptoms. All patients had a positive exercise stress test and were referred for an invasive evaluation. Patients underwent a study protocol with an invasive diagnostic procedure (IDP) consisting of measurements of FFR and IMR in at least one coronary vessel. Exclusion criteria are acute coronary syndromes, known coronary artery disease, previous myocardial infarction, previous revascularization, and abnormal baseline electrocardiogram (ECG). All data were centrally collected and analyzed by the core laboratory. The primary objective was to determine the false discovery rate of exercise stress tests using an interventional diagnostic procedure (IDP) with indexes of epicardial (FFR) and microvascular resistance (IMR) as clinical references. The secondary objective was to assess the impact of an IDP accounting for the presence of CMD on the accuracy of exercise stress tests.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Index of Microvascular Resistance	The invasive diagnostic procedure will be performed in at least one coronary artery. The left anterior descending coronary artery will be the preferred target vessel; however, if technical factors precluded guidewire-based assessment of this artery (e.g., tortuous anatomy), then the left circumflex or right coronary artery can be selected. In the case of multiple measurements per patient, the lowest FFR or highest IMR will be used for analysis. A coronary wire with a pressure and temperature sensor (PressureWire X, Abbott Vascular, Santa Clara, CA, USA) will be advanced to the mid to distal segment of the coronary artery. Bolus thermodilution technique with three 3-cc saline injections in rest and hyperemia will be used.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-11-01
• Completion: 2021-12-31
• First posted: 2022-02-09
• Last updated: 2022-02-09

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study