Diagnostic Performance of Exercise Stress Tests for the Detection of Epicardial and Microvascular Coronary Artery Disease (UZ Clear)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Index of Microvascular Resistance

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.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Belgium
  • Oost Vlanderen
    • Aalst, Oost Vlanderen, Belgium, 9300
      • OLV Aalst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Stable patients suspected of having coronary artery disease based on the presence of stable angina-like chest pain

Description

Inclusion Criteria:

- 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 Criteria:

1. Age <30 or >80-year old
2. Acute coronary syndromes.
3. Known coronary artery disease
4. Inability to perform exercise tests.
5. Previous myocardial infarction.
6. Previous CABG/PCI
7. Left ventricular dysfunction EF <35% or NYHA class III-IV
8. Uncontrolled or recurrent ventricular tachycardia
9. Atrial fibrillation
10. Severe renal dysfunction, defined as an eGFR <30 ml/min/1.73m2
11. Contra-indication to adenosine (e.g. asthma bronchial, severe COPD)
12. Active cancer
13. Recent stroke
14. Cardiomyopathy (dilated, hypertrophic, amyloidosis, arrhythmogenic right ventricular dysplasia)
15. Left Bundle Branch Block or baseline ST-segment depression >1mm.
16. Congenital heart disease
17. More than moderate valve disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Diagnostic performance of exercise tests with false discovery rate	Immediately post-procedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to assess the impact of an IDP accounting for the presence of CMD on the accuracy of exercise stress tests.	Comparison of false discovery rates using QCA, FFR and IMR as gold standards	Immediately post-procedural

Collaborators and Investigators

• Sponsor: Onze Lieve Vrouw Hospital
• Collaborators: Centro Cardiologico Monzino

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CRI-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Sharing of IPD is not foressen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes