NCT01393028

Brief Summary

Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve the workup of patients with stable chest pain complaints. The objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven workup of suspected coronary artery disease in comparison to the standard workup using stress testing.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

3.1 years

First QC Date

June 27, 2011

Last Update Submit

November 11, 2014

Conditions

Angina PectorisChest Pain

Keywords

coronary artery diseaseangina pectorisStable chest pain complaints

Outcome Measures

Primary Outcomes (2)

  • Chest pain

    Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up

    1 year

  • Class IA Revascularizations

    Number of revascularizations with an ESC class 1A indication

    1 year

Secondary Outcomes (5)

  • Overall medical expenses

    1 year

  • Cost-effectiveness

    1 year

  • Radiation dose

    1 year

  • Major adverse cardiovascular events

    1 year

  • Quality of life

    1 year

Study Arms (2)

Cardiac CT

EXPERIMENTAL

Cardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result

Other: Cardiac CT

Standard care

OTHER

Standard diagnostic management, including stress testing and/or invasive angiography

Other: Standard care

Interventions

Cardiac CTOTHER

Cardiac CT: calcium scan and CT coronary angiography

Cardiac CT
Standard careOTHER

Standard care according to international guidelines

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged \>18 years.
  • Stable symptoms of chest pain or dyspnea potentially caused by obstructive CAD.

You may not qualify if:

  • A history of surgical or percutaneous coronary revascularization
  • Non-revascularized angiographic obstructive coronary artery disease (\>50% diameter reduction).
  • Normal invasive coronary angiography or stress imaging less than 1 years ago.
  • Inability or unwillingness to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

MC Haaglanden

Leidschendam, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Havenziekenhuis

Rotterdam, Netherlands

Location

Maasstadziekenhuis

Rotterdam, Netherlands

Location

Related Publications (1)

  • Lubbers M, Coenen A, Bruning T, Galema T, Akkerhuis J, Krenning B, Musters P, Ouhlous M, Liem A, Niezen A, Dedic A, van Domburg R, Hunink M, Nieman K. Sex Differences in the Performance of Cardiac Computed Tomography Compared With Functional Testing in Evaluating Stable Chest Pain: Subanalysis of the Multicenter, Randomized CRESCENT Trial (Calcium Imaging and Selective CT Angiography in Comparison to Functional Testing for Suspected Coronary Artery Disease). Circ Cardiovasc Imaging. 2017 Feb;10(2):e005295. doi: 10.1161/CIRCIMAGING.116.005295.

    PMID: 28174196DERIVED

MeSH Terms

Conditions

Angina PectorisChest PainCoronary Artery Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr K Nieman

Study Record Dates

First Submitted

June 27, 2011

First Posted

July 13, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

NL(4)