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

Coronary Artery Disease Clinical Trial

— CRESCENT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291484
• Other study ID #: MEC2013022
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2014
• Last updated: August 3, 2016
• Start date: August 2013
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina Pectoris

Intervention

Device:
• Cardiac CT scan
CT-guided management

Locations

Country	Name	City	State
Netherlands	Albert Schweizerzieknhuis	Dordrecht
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus MC	Rotterdam
Netherlands	Maasstadziekenhuis	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of negative invasive angiograms (as percentage of total population)	Number of performed invasive angiograms with no CAD requiring intervention	6 months	No
Secondary	Chest pain complaints	Proportion of patients experiencing symptoms of chest pain	6 months	No
Secondary	Quality of life	Questionnaire based quality of life score	6 months	No
Secondary	Major adverse event rate	Death, myocardial infarction, unstable angina, urgent revascularizations, CVA	6 months	Yes
Secondary	Radiation exposure	Cumulative radiation dose from diagnostic and therapeutic interventions	6 months	Yes
Secondary	Number of diagnostic and therapeutic procedures	Number of diagnostic and therapeutic procedures	6 months	No
Secondary	Medical expenses	All medical expenses related to the diagnosis and treatment of suspected CAD	6 months	No