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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list