Clinical Trial on the Therapy of the Reperfusion Injury during an Acute Myocardial Infarction
| ISRCTN | ISRCTN80646081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80646081 |
| Protocol serial number | N/A |
| Sponsor | German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) |
| Funder | German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) |
- Submission date
- 13/06/2005
- Registration date
- 01/09/2005
- Last edited
- 21/05/2008
- 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
Ms Rabea Hinkel
Scientific
Scientific
Klinikum Großhadern
Internal Medicine I
Marchioninistr. 15
Munich
81377
Germany
| Phone | +49 (0)89 7095 3075 |
|---|---|
| rabea.hinkel@med.uni-muenchen.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Myoprotect II |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acute myocardial infarction |
| Intervention | Randomised controlled trial: A. Glutathione (GSH)/Cariporide B. Placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Glutathione (GSH), Cariporide |
| Primary outcome measure(s) |
Regional myocardial function 6 months after revascularisation |
| Key secondary outcome measure(s) |
Infarct size, left ventricular ejection fraction |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | Age: 18-80, 1-6 hours after onset of chest pain, clinic and electrocardiogram (ECG) of an acute myocardial infarction, written informed consent |
| Key exclusion criteria | 1. Myocardial infarction within 28 days 2. Lysis therapy within 24 hours 3. Cardiogenic shock |
| Date of first enrolment | 01/07/2001 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinikum Großhadern
Munich
81377
Germany
81377
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
