Condition category
Circulatory System
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
05/11/2008
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 M. Lobbes

ORCID ID

Contact details

University Hospital of Maastricht
Department of Radiology
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3874910
mlob@rdia.azm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR376

Study information

Scientific title

The association between new and established serum markers in cardiovascular disease

Acronym

Study hypothesis

We hypothesise that our newly discovered serum risk markers are positively associated with the presence of cardiovascular diseases.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, single-blind, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Cardiovascular disease

Intervention

In the groups AMI, SAP, UAP and controls, the marker concentrations of several potential new risk markers for cardiovascular diseases will be evaluated at inclusion, after 6 months, and after 12 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

(Recurrent) cardiovascular disease e.g. myocardial infarction (MI), SAP, UAP, mortality

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2004

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Groups of acute myocardial infarction (AMI), stable angina pectoris (SAP), unstable angina pectoris (UAP) and controls will be formed (n = 120). All participants will donate a venous blood sample at inclusion, and after 6 and 12 months. Marker concentration will be evaluated in these blood samples.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

1. Unable to give informed consent
2. Cardiovascular disease (CVD) less than 6 months
3. Auto-immune diseases
4. Malignancies
5. Renal insufficiency (less than 40 ml/min creatinine clearance)

Recruitment start date

01/11/2004

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Hospital of Maastricht
Maastricht
6202 AZ
Netherlands

Sponsor information

Organisation

University Hospital Maastricht (AZM) (The Netherlands)

Sponsor details

P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 387 6543
info@azm.nl

Sponsor type

Hospital/treatment centre

Website

http://www.unimaas.nl/

Funders

Funder type

Research organisation

Funder name

Netherlands Heart Foundation (Nederlandse Hartstichting) (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