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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN43894092
• Date of registration: 02/03/2007
• Prospective Registration: No
• Primary sponsor: Erasmus Medical Centre (The Netherlands)
• Public title: Multislice computed tomography coronary angiography in patients with stable and unstable angina: a multicentre study
• Date of first enrolment: 15/11/2004
• Target sample size: 320
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN43894092
• Study type: Interventional
• Study design: Prospective multicentre non-randomised study (Diagnostic)

Countries of recruitment

Netherlands

Contacts

• Name: Pim J de Feyter

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Angina pectoris
Circulatory System
Angina

Intervention(s)

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).

Primary Outcome(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.

Secondary Outcome(s)

No secondary outcome measures

Secondary ID(s)

ZonMw: 945-04-263, NTR490

Source(s) of Monetary Support

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