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

Sponsor

Erasmus Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02291484

Collaborator

(none)

250

Enrollment

Locations

Arms

Duration (Months)

62.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Pectoris Coronary Artery Disease	Device: Cardiac CT scan	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of negative invasive angiograms (as percentage of total population) [6 months]
Number of performed invasive angiograms with no CAD requiring intervention

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Albert Schweizerzieknhuis	Dordrecht	Netherlands	3318 AT
2	Maastricht University Medical Center	Maastricht	Netherlands	6229 HX
3	Erasmus MC	Rotterdam	Netherlands	3015CE
4	Maasstadziekenhuis	Rotterdam	Netherlands