|- candidate number||1466|
|- NTR Number||NTR490|
|- Date ISRCTN created||2-mrt-2007|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||8-sep-2005|
|- Secondary IDs||945-04-263 ZonMW|
|- Public Title||Multislice computed tomography coronary angiography in patients with stable and unstable angina: a multicenter study.|
|- Scientific Title||Multislice computed tomography coronary angiography in patients with stable and unstable angina: a multicenter study.|
|- hypothesis||Is diagnostic non-invasive coronary angiography with 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 revascularization (percutaneous coronary intervention or coronary bypass surgery).|
|- Healt Condition(s) or Problem(s) studied||Angina Pectoris|
|- 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.
a) male and female younger than 70 years,
b) stable angina pectoris that warrants further evaluation by coronary angiography and revascularization by percutaneous coronary intervention,
c) stable heart rhythm,
d) heart rate less than 70 b.p.m. (either spontaneous or drug-induced) and
e) no contra indications such as severe renal or pulmonary dysfunction or X-ray contrast intolerance.
|- Exclusion criteria||Patients will be excluded if they are: |
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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-nov-2004|
|- planned closingdate||15-aug-2007|
|- Target number of participants||320|
|- Interventions||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 breathhold of 20 seconds.
The whole procedure, including patient instruction, preparation and data acquisition requires about 10-15 minutes.
The scan is performed by a technician under supervision of a cardiologist or radiologist. Postprocessing 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||Diagnostic accuracy in terms of sensitivity, specificity and predictive value of MS-CT to detect significant obstructive coronary lesions (>50% lumenal diameter reduction with 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||N/A|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. Pim J. Feyter, de|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Pim J. Feyter, de|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Cardiology and Radiology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The study is a prospective multicenter non-randomized study. Three centers will be involved of which 2 centers are University Hospitals |
1) Erasmus Medical Center and
2) Utrecht Medical Center and one affiliated teaching hospital: Antonius Ziekenhuis Nieuwegein.
The Erasmus MC will enroll 60 stable and 60 unstable patients while the other two participating center will enroll 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 2 investigators (1 cardiologist, 1 radiologist) unaware of the outcome of the subsequent diagnostic angiogram. In case of disagreement consensus will be achieved by a third reader.
All patients, independent of the outcome of the scan, will be scheduled for diagnostic coronary angiography. The diagnostic coronary angiogram will be separately assessed by two cardiologists, unaware of the outcome of the MS-CT scan.
Quantification of coronary stenoses will be performed using automated contour detection algorithms (QCA).
|- Main changes (audit trail)|
|- RECORD||8-sep-2005 - 9-dec-2009|