Condition category
Circulatory System
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
26/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J J Bax

ORCID ID

Contact details

Leiden University Medical Centre (LUMC)
Department of Cardiology
P.O. Box 9600
Albinusdreef 2
Leiden
2300 RC
Netherlands
+31 (0)71 526 2020
j.j.bax@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

In patients presenting with chest pain complaints and an intermediate risk of Coronary Artery Disease (CAD), Multi-Slice Computed Tomography (MSCT) will have a higher specificity as compared to Myocardial Perfusion Imaging (MPI). Accordingly, MSCT may serve as an accurate first-line evaluation tool.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Non-randomised, non-controlled, interventional clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Angina Pectoris, Coronary artery disease

Intervention

MSCT coronary angiography in addition to MPI

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

MSCT may improve (as compared to MPI) the diagnosis of patients presenting with chest pain complaints and an intermediate likelihood of CAD. Particularly in these patients, a non-invasive test with a high specificity (to exclude CAD) is needed to allow optimal management of patients. Currently, MPI is used for this purpose, but the specificity of MPI is suboptimal (70%).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2004

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (having obtained legal majority age) with chest pain complaints
2. An intermediate pre-test likelihood of CAD (based on the Diamond and Forrester method)
3. The need for additional imaging studies to evaluate the presence/absence of CAD

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Fertile women
2. Patients with severe renal failure
3. Patients presenting with a known allergy to iodine contrast media
4. Patients included in another clinical trial
5. Patients under guardianship
6. Patients whose degree of cooperation is incompatible with carrying out the study

Recruitment start date

01/10/2004

Recruitment end date

01/10/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Department of Cardiology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html

Funders

Funder type

Charity

Funder name

Netherlands Heart Foundation (Nederlandse Hartstichting) (NHS) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes