Multislice computed tomography coronary angiography in patients with stable and unstable angina: a multicentre study

ISRCTN	ISRCTN43894092
DOI	https://doi.org/10.1186/ISRCTN43894092
Protocol serial number	ZonMw: 945-04-263, NTR490
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 02/03/2007
Registration date: 02/03/2007
Last edited: 17/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pim J de Feyter
Scientific

Erasmus Medical Centre
Department of Cardiology and Radiology
P.O. Box 2040
Dr. Molewaterplein 40
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 463 5070
Email	p.j.defeyter@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Prospective multicentre non-randomised study
Secondary study design	Non randomised controlled trial
Scientific title
Study objectives	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(s)	Approval received from the Medisch Ethische Toetsings Commissie Erasmus MC on the 19th November 2004 (ref: MEC-2004-274).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	15/08/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	320
Key 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
Key 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
Date of first enrolment	15/11/2004
Date of final enrolment	15/08/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Centre

Rotterdam
3000 CA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan