Condition category
Circulatory System
Date applied
02/03/2007
Date assigned
02/03/2007
Last edited
17/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pim J de Feyter

ORCID ID

Contact details

Erasmus Medical Centre
Department of Cardiology and Radiology
P.O. Box 2040
Dr. Molewaterplein 40
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 5070
p.j.defeyter@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw: 945-04-263, NTR490

Study information

Scientific title

Acronym

Study hypothesis

Is diagnostic non-invasive coronary angiography with Multislice Computed Tomography (MS-CT) a cost-effective alternative to diagnostic invasive coronary angiography in the management of patients with stable and unstable angina pectoris, referred for evaluation of the presence of significant coronary obstructions to determine further treatment strategies consisting of medical treatment, or revascularisation (percutaneous coronary intervention or coronary bypass surgery)?

Ethics approval

Approval received from the Medisch Ethische Toetsings Commissie Erasmus MC on the 19th November 2004 (ref: MEC-2004-274).

Study design

Prospective multicentre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Angina pectoris

Intervention

Three centres will be involved of which two centres are University Hospitals:
1. Erasmus Medical Centre, and
2. Utrecht Medical Centre
And one affiliated teaching hospital:
3. Antonius Ziekenhuis Nieuwegein

The Erasmus MC will enrol 60 stable and 60 unstable patients while the other two participating centres will enrol 50 - 60 stable and 50 - 60 unstable patients.

All patients will first undergo a non-invasive MS-CT coronary angiogram. The outcome of the MS-CT scan in terms of presence and location of significant coronary obstruction(s) will be separately assessed by two investigators (one cardiologist, one radiologist) unaware of the outcome of the subsequent diagnostic angiogram. In case of disagreement a third reader will achieve consensus. All patients, independent of the outcome of the scan, will be scheduled for diagnostic coronary angiography. Two cardiologists, unaware of the outcome of the MS-CT scan, will separately assess the diagnostic coronary angiogram.

MS-CT coronary angiography:
An MS-CT coronary angiogram is performed using a bolus injection of 100 ml contrast agent into a brachial vein. The scan is made during a breath-hold of 20 seconds. The whole procedure, including patient instruction, preparation and data acquisition requires about 10 - 15 minutes. A technician under supervision of a cardiologist or radiologist performs the scan. Post-processing and reading of the images requires another 10 - 20 minutes, which is done off-line by a cardiologist and radiologist. It is expected that faster post-processing tools will become available which will significantly reduce MS-CT reading time. A Siemens 16 slice MS-CT (EMC, Rotterdam) and a Philips 16-slice MS-CT (UMC, Utrecht; Antonius Hospital Nieuwegein).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Diagnostic accuracy in terms of sensitivity, specificity and predictive value of MS-CT to detect significant obstructive coronary lesions (more than 50% lumenal diameter reduction with Quantitative Angiography [QCA]) using the diagnostic invasive coronary angiogram as the reference standard.

The costs, effectiveness, and the cost-effectiveness of non-invasive MS-CT coronary angiography as an initial test will be compared to diagnostic invasive coronary angiography.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/11/2004

Overall trial end date

15/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Symptomatic patients with stable angina (N = 160) and unstable angina (N = 160) who are scheduled for diagnostic invasive coronary angiography will be enrolled into the study. In addition these patients also need to fulfill the following inclusion criteria:
1. Male and female younger than 70 years
2. Stable angina pectoris that warrants further evaluation by coronary angiography and revascularisation by percutaneous coronary intervention
3. Stable heart rhythm
4. Heart rate less than 70 beats per minute (either spontaneous or drug-induced)
5. No contra-indications such as severe renal or pulmonary dysfunction or X-ray contrast intolerance

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

320

Participant exclusion criteria

1. Older than 70 years, and
2. Have an irregular heart rhythm (predominantly atrial fibrillation), or
3. Have severe renal or pulmonary dysfunction or X-ray contrast intolerance

Recruitment start date

15/11/2004

Recruitment end date

15/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Cardiology and Radiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes