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NCT Number: NCT05231161

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV Aalst

Aalst, Oost Vlanderen, 9300, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.
  • Positive non-invasive exercise test, or inconclusive stress with additional positive imaging.

Exclusion criteria

  • 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.
  • Congenital heart disease
  • More than moderate valve disease

Treatment and study plan

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.

Other names: Fractional Flow Reserve

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.

    Time frame: Immediately post-procedural

    Diagnostic performance of exercise tests with false discovery rate

Secondary outcomes

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

    Time frame: Immediately post-procedural

    Comparison of false discovery rates using QCA, FFR and IMR as gold standards

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouw Hospital

Other

Collaborators

  • Centro Cardiologico Monzino

Registry information

Acronym: UZ Clear

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2022
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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