Clinical Trial on the Therapy of the Reperfusion Injury during an Acute Myocardial Infarction
| ISRCTN | ISRCTN80646081 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80646081 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Glutathione (GSH), Cariporide |
| Primary outcome measure | Regional myocardial function 6 months after revascularisation |
| Secondary outcome measures | Infarct size, left ventricular ejection fraction |
| Overall study start date | 01/07/2001 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG)
Research organisation
Research organisation
Kennedyalle 40
Bonn
53175
Germany
| Phone | +49 (0)228 885 2552 |
|---|---|
| Petra.Hintze@dfg.de | |
| Website | http://www.dfg.de |
"ROR" |
https://ror.org/018mejw64 |
Funders
Funder type
Research organisation
German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
