We expect that Myocardial Perfusion Imaging will show significantly more frequent ischemia in the case of a positive EBCT than in the case of a positive ETT.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ischemia on the MIBI scan is the primary endpoint of this study. The predictive
value for the occurence of ischemia on the MIBI scan will be compared between
positive EBCT and positive ETT test results.
Secondary outcome
n.a.
Background summary
Coronary heart disease is the most frequent cause of death in the Netherlands.
It frequently presents with chest pain, which is the common complaint in
practice of the general practitioner (GP). The Exercise Tolerance Test (ETT) is
used by GP to objectivate the risk of the patient with chest pain for the
ischemic heart disease. But ETT has several important disadvantages. The
patient has to be able to bike well for this test, which does not always occur.
The another disadvantage is that the negative ETT result can not exclude the
presence of atherosclerosis.
Therefore a better investigation procedure is required for the patients with
chest pain. Electron Beam Computed Tomography (EBCT) is a new CT scan, which
performs the calcification in coronary arteries. The risk for the
cardiovascular events can be determined using the calcification scores of
EBCT.
Study objective
We expect that Myocardial Perfusion Imaging will show significantly more
frequent ischemia in the case of a positive EBCT than in the case of a positive
ETT.
Study design
This study is a cooperation of the departments of Cardiology, Radiology and
General Practitioner Medicine of University Medical Centre Groningen (UMCG).
The GP will refer the patients with typical angina pectoris complaints for the
ETT to the LabNoord. The patients will be given an explanation about the study
design by the GP. The patients who agree with the participation in this
research will undergo EBCT in the UMCG.
The outcomes of EBCT and ETT will be compared by the cardiologist and the
radiologist of the UMCG. The results of both investigational methods will be
sent to the GP with the commentary of the cardiologist. We will evaluate the
patients by keeping telephone contact with them (during) after one year of
follow-up. The patients will be asked about the developing of the cardiac
events, the reference to the specialist and the determination of the diagnosis.
Intervention
The patients will undergo the ETT and EBCT. The patient with negative results
of both investigations will be reassured by GP. If one of the investigations
will show any abnormalities, the GP is advised to refer the patient to a
cardiologist for additional diagnostic procedures (Myocardial Imaging Perfusion
scan; MIBI).
Study burden and risks
EBCT has a radiation of 2 mSV. We do not expect that this will have any
disadvantages for the patients.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
1) patients above the age of 40 years and below 75 years
2) patients with typical angina pectoris complaints
3) patients without a history of cardiac event
Exclusion criteria
1) patients with myocardial infarct, coronary artery bypass graft and/or percutaneous transluminal coronary angioplasty in the medical history
2) pregnant patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11801.042.06 |