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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Stable Angina Pectoris
• Intervention / Treatment: Device: Cardiac CT scan

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweizerzieknhuis
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • Rotterdam, Netherlands, 3015CE
    • Erasmus MC
  • Rotterdam, Netherlands
    • Maasstadziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive cardiac CT; Tiered cardiac CT protocol: CT calcium scan; CT angiography (if calcium scan positive or high pre-test probability); CT perfusion (if >50% stenosis on CTA, or cannot be ruled out)	Device: Cardiac CT scan; CT-guided management
No Intervention: Standard care; Standard diagnostic management of suspected CAD, using stress testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of negative invasive angiograms (as percentage of total population)	Number of performed invasive angiograms with no CAD requiring intervention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest pain complaints	Proportion of patients experiencing symptoms of chest pain	6 months
Quality of life	Questionnaire based quality of life score	6 months
Major adverse event rate	Death, myocardial infarction, unstable angina, urgent revascularizations, CVA	6 months
Radiation exposure	Cumulative radiation dose from diagnostic and therapeutic interventions	6 months
Number of diagnostic and therapeutic procedures	Number of diagnostic and therapeutic procedures	6 months
Medical expenses	All medical expenses related to the diagnosis and treatment of suspected CAD	6 months

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Koen Nieman, MD, PhD, Erasmus Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 11, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Coronary angiography; Coronary artery disease; Randomized controlled trial; Computed tomography; Cost-effectiveness; Comparative effectiveness; Perfusion imaging
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: MEC2013022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO