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

Coronary Artery Disease Clinical Trial

— UZ Clear  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05231161
• Other study ID #: CRI-100
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 31, 2021
• Est. primary completion date: November 1, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst	Oost Vlanderen

Sponsors (2)

Lead Sponsor	Collaborator
Onze Lieve Vrouw Hospital	Centro Cardiologico Monzino

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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