The association between new and established cardiovascular serum markers
| ISRCTN | ISRCTN79274394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79274394 |
| Protocol serial number | NTR376 |
| Sponsor | University Hospital Maastricht (AZM) (The Netherlands) |
| Funder | Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands) |
- 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
Scientific
University Hospital of Maastricht
Department of Radiology
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
| Phone | +31 (0)43 3874910 |
|---|---|
| mlob@rdia.azm.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single-blind, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The association between new and established serum markers in cardiovascular disease |
| Study objectives | We 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) studied | 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 |
| Primary outcome measure(s) |
(Recurrent) cardiovascular disease e.g. myocardial infarction (MI), SAP, UAP, mortality |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Hospital of Maastricht
Maastricht
6202 AZ
Netherlands
6202 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
