Skip to main content
OpenTrials
Completed

NCT Number: NCT02291484

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stable Angina Pectoris Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Albert Schweizerzieknhuis, Dordrecht, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac CT scan

Device

CT-guided management

Primary outcomes

  1. Rate of negative invasive angiograms (as percentage of total population)

    Time frame: 6 months

    Number of performed invasive angiograms with no CAD requiring intervention

Secondary outcomes

  1. Chest pain complaints

    Time frame: 6 months

    Proportion of patients experiencing symptoms of chest pain

  2. Quality of life

    Time frame: 6 months

    Questionnaire based quality of life score

  3. Major adverse event rate

    Time frame: 6 months

    Death, myocardial infarction, unstable angina, urgent revascularizations, CVA

  4. Radiation exposure

    Time frame: 6 months

    Cumulative radiation dose from diagnostic and therapeutic interventions

  5. Number of diagnostic and therapeutic procedures

    Time frame: 6 months

    Number of diagnostic and therapeutic procedures

  6. Medical expenses

    Time frame: 6 months

    All medical expenses related to the diagnosis and treatment of suspected CAD

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: CRESCENT2

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 14, 2014
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.