Multislice computed tomography coronary angiography in patients with stable and unstable angina: a multicentre study
ISRCTN | ISRCTN43894092 |
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DOI | https://doi.org/10.1186/ISRCTN43894092 |
Secondary identifying numbers | ZonMw: 945-04-263, NTR490 |
- 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
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 |
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p.j.defeyter@erasmusmc.nl |
Study information
Study design | Prospective multicentre non-randomised study |
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Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | Hospital |
Study type | Diagnostic |
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 | 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 study start date | 15/11/2004 |
Completion date | 15/08/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Cardiology and Radiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Website | http://www.erasmusmc.nl/ |
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https://ror.org/018906e22 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |