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

NCT05231161 | Completed FDA Drug

• 1 other identifier: CRI-100
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to assess the impact of an IDP accounting for the presence of CMD on the accuracy of exercise stress tests.

  Immediately post-procedural

Interventions

Index of Microvascular Resistance DIAGNOSTIC_TEST

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.

Also known as: Fractional Flow Reserve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \- 1. Stable angina-like chest pain (typical or atypical) with intermediate (15-85%) pre-test probability of coronary artery disease using the ESC criteria.
• \. Positive non-invasive exercise test, or inconclusive stress with additional positive imaging.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead
• Centro Cardiologico Monzino: collaborator

Study Sites (1)

OLV Aalst

Aalst, Oost Vlanderen, 9300, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-director Cardiovascular Center OLV Aalst

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: December 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: December 31, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)