NCT02291484

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2013

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

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

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

November 11, 2014

Last Update Submit

August 3, 2016

Conditions

Stable Angina PectorisCoronary Artery Disease

Keywords

Computed tomographyCoronary angiographyCoronary artery diseasePerfusion imagingComparative effectivenessRandomized controlled trialCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • Rate of negative invasive angiograms (as percentage of total population)

    Number of performed invasive angiograms with no CAD requiring intervention

    6 months

Secondary Outcomes (6)

  • Chest pain complaints

    6 months

  • Quality of life

    6 months

  • Major adverse event rate

    6 months

  • Radiation exposure

    6 months

  • Number of diagnostic and therapeutic procedures

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Comprehensive cardiac CT

EXPERIMENTAL

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)

Device: Cardiac CT scan

Standard care

NO INTERVENTION

Standard diagnostic management of suspected CAD, using stress testing

Interventions

Cardiac CT scanDEVICE

CT-guided management

Comprehensive cardiac CT

Eligibility Criteria

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

You may qualify if:

  • Men and women aged \>18 years.
  • Chest pain symptoms suspicious of coronary heart disease.
  • Pre-test probability of coronary artery disease \>10%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Albert Schweizerzieknhuis

Dordrecht, 3318 AT, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

Erasmus MC

Rotterdam, 3015CE, Netherlands

Location

Maasstadziekenhuis

Rotterdam, Netherlands

Location

Related Publications (1)

  • Lubbers M, Coenen A, Kofflard M, Bruning T, Kietselaer B, Galema T, Kock M, Niezen A, Das M, van Gent M, van den Bos EJ, van Woerkens L, Musters P, Kooij S, Nous F, Budde R, Hunink M, Nieman K. Comprehensive Cardiac CT With Myocardial Perfusion Imaging Versus Functional Testing in Suspected Coronary Artery Disease: The Multicenter, Randomized CRESCENT-II Trial. JACC Cardiovasc Imaging. 2018 Nov;11(11):1625-1636. doi: 10.1016/j.jcmg.2017.10.010. Epub 2017 Dec 13.

    PMID: 29248657DERIVED

MeSH Terms

Conditions

Angina, StableCoronary Artery Disease

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Koen Nieman, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

November 11, 2014

First Posted

November 14, 2014

Study Start

August 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(4)