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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20510
Enrollment
320
Registered
2005-09-08
Start date
2004-11-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 wh
Antonius Hospital Nieuwegein).

Sponsors

ZonMw NL
Lead Sponsor

Eligibility

Inclusion 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. 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

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.

Design outcomes

Primary

MeasureTime frame
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.

Contacts

Public ContactPim J. Feyter, de

Erasmus Medical Center, Department of Cardiology and Radiology, P.O. Box 2040

p.j.defeyter@erasmusmc.nl+31 (0)10 4635070

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)