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
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