Clinical trial NCT02291484: Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)
Official title: Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stable Angina Pectoris
Coronary Artery Disease
Keywords: Computed tomography
Coronary angiography
Coronary artery disease
Perfusion imaging
Comparative effectiveness
Randomized controlled trial
Cost-effectiveness
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of negative invasive angiograms (as percentage of total population)
timeFrame: 6 months
Secondary outcomes:
measure: Chest pain complaints
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Major adverse event rate
timeFrame: 6 months
measure: Radiation exposure
timeFrame: 6 months
measure: Number of diagnostic and therapeutic procedures
timeFrame: 6 months
measure: Medical expenses
timeFrame: 6 months
Other outcomes:
Locations:
city: Dordrecht
country: Netherlands
facility: Albert Schweizerzieknhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Maasstadziekenhuis
Study officials:
affiliation: Erasmus Medical Center
name: Koen Nieman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lubbers M, Coenen A, Kofflard M, Bruning T, Kietselaer B, Galema T, Kock M, Niezen A, Das M, van Gent M, van den Bos EJ, van Woerkens L, Musters P, Kooij S, Nous F, Budde R, Hunink M, Nieman K. Comprehensive Cardiac CT With Myocardial Perfusion Imaging Versus Functional Testing in Suspected Coronary Artery Disease: The Multicenter, Randomized CRESCENT-II Trial. JACC Cardiovasc Imaging. 2018 Nov;11(11):1625-1636. doi: 10.1016/j.jcmg.2017.10.010. Epub 2017 Dec 13.