Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2) (CRESCENT2)

Erasmus University

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease; Stable Angina Pectoris

Treatments: Device: Cardiac CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02291484

MEC2013022

Details and patient eligibility

About

Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.

Full description

Rationale: CT calcium and coronary lumen imaging allow efficient exclusion of coronary artery disease (CAD), but cannot assess the hemodynamic significance of obstructive findings. Addition of stress myocardial perfusion imaging, which assesses the functional relevance of coronary narrowing, completes the non-invasive cardiac evaluation.

Hypothesis: A comprehensive cardiac CT examination will allow fast, accurate and complete evaluation of suspected CAD.

Objective: evaluate the effectiveness and efficiency of comprehensive cardiac CT workup of suspected CAD.

Study design: Open-labelled, randomized-controlled, clinical efficiency trial, with an intention-to-diagnose approach, between CT-guided management and the current standard of care (based on functional testing of provocable myocardial ischemia) in patients with suspected CAD.

Study population: 250 patients (>18 yrs) with stable chest complaints, a >10% pre-test probability of CAD, and referred for evaluation of possible CAD.

Intervention: Instead of the usual diagnostic approach, patients in the intervention group will undergo in sequence the following CT examinations: coronary calcium scan, coronary CT angiography and CT myocardial perfusion imaging, with completion dependent on results. Findings on CT will direct further management.

Main study parameters/endpoints:

Primary: Rate of negative invasive angiograms (as percentage of total population) Secondary: Diagnostic yield, chest complaints, quality of life, diagnostic and therapeutic procedures, overall costs and adverse events at 6 months.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged >18 years.
• Chest pain symptoms suspicious of coronary heart disease.
• Pre-test probability of coronary artery disease >10%

Exclusion criteria

• History of CAD: prior myocardial infarction or revascularization procedure
• Contra-indication to radiation exposure (CT/SPECT): pregnancy
• Contra-indication to iodine contrast media: renal failure, iodine allergy
• Contra-indications to adenosine
• Inability or unwillingness to provide informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Comprehensive cardiac CT

Experimental group

Description:

Tiered cardiac CT protocol: 1. CT calcium scan 2. CT angiography (if calcium scan positive or high pre-test probability) 3. CT perfusion (if \>50% stenosis on CTA, or cannot be ruled out)

Treatment:

Device: Cardiac CT scan

Standard care

No Intervention group

Description:

Standard diagnostic management of suspected CAD, using stress testing