Non-invasive assessment of coronary artery disease in patients with chest pain

ISRCTN	ISRCTN65675235
DOI	https://doi.org/10.1186/ISRCTN65675235
Secondary identifying numbers	NL446 (NTR486)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr J J Bax
Scientific

Leiden University Medical Centre (LUMC)
Department of Cardiology
P.O. Box 9600
Albinusdreef 2
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 2020
Email	j.j.bax@lumc.nl

Study design	Non-randomised, non-controlled, interventional clinical trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Non-invasive assessment of coronary artery disease in patients with chest pain
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Angina Pectoris, Coronary artery disease
Intervention	MSCT coronary angiography in addition to MPI
Intervention type	Other
Primary outcome measure	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 study start date	01/10/2004
Completion date	01/10/2007

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	100
Total final enrolment	100
Key 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
Key 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
Date of first enrolment	01/10/2004
Date of final enrolment	01/10/2007

Leiden University Medical Centre (LUMC)

Leiden
2300 RC
Netherlands

Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre

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

Website	http://www.lumc.nl/english/start_english.html
"ROR"	https://ror.org/027bh9e22

Charity

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

No information available

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		07/11/2006	26/03/2021	Yes	No

26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.