The association between new and established cardiovascular serum markers

ISRCTN ISRCTN79274394
DOI https://doi.org/10.1186/ISRCTN79274394
Secondary identifying numbers NTR376
Submission date
19/12/2005
Registration date
19/12/2005
Last edited
05/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M. Lobbes
Scientific

University Hospital of Maastricht
Department of Radiology
P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Phone +31 (0)43 3874910
Email mlob@rdia.azm.nl

Study information

Study designRandomised, single-blind, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific titleThe association between new and established serum markers in cardiovascular disease
Study objectivesWe hypothesise that our newly discovered serum risk markers are positively associated with the presence of cardiovascular diseases.
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedCardiovascular disease
InterventionIn 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 typeOther
Primary outcome measure(Recurrent) cardiovascular disease e.g. myocardial infarction (MI), SAP, UAP, mortality
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/11/2004
Completion date01/05/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants120
Key inclusion criteriaGroups 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.
Key exclusion criteria1. 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)
Date of first enrolment01/11/2004
Date of final enrolment01/05/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Hospital of Maastricht
Maastricht
6202 AZ
Netherlands

Sponsor information

University Hospital Maastricht (AZM) (The Netherlands)
Hospital/treatment centre

P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Phone +31 (0)43 387 6543
Email info@azm.nl
Website http://www.unimaas.nl/
ROR logo "ROR" https://ror.org/02d9ce178

Funders

Funder type

Research organisation

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan