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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stable Angina Pectoris Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Comprehensive cardiac CT

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)

Group Type EXPERIMENTAL

Cardiac CT scan

Intervention Type DEVICE

CT-guided management

Standard care

Standard diagnostic management of suspected CAD, using stress testing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cardiac CT scan

CT-guided management

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No