Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05231161
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2022-01-28
Brief Title:
Diagnostic Performance of Exercise Stress Tests for the Detection of Epicardial and Microvascular Coronary Artery Disease
Sponsor:
Onze Lieve Vrouw Hospital
Organization:
Onze Lieve Vrouw Hospital
Study Overview
Official Title:
Diagnostic Performance of Exercise Stress Tests for the Detection of Epicardial and Microvascular Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UZ Clear
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None