HYbrid-Revascularisation In Senescent Cohorts: a prospective randomised comparative trial between minimally-invasive coronary revascularisation treatment without extra-corporeal circulation (off pump coronary surgery) and combined stent-implantation versus conventionally surgical treatment in cardioplegia with the aid of extra-corporeal circulation
| ISRCTN | ISRCTN53284852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53284852 |
| Protocol serial number | KKSH-018/1 |
| Sponsor | Martin Luther-University Halle-Wittenberg (Germany) |
| Funder | Self-funded by the Department of Cardiothoracic Surgery and Cardiology, Martin-Luther-University Halle (Germany) |
- Submission date
- 05/01/2007
- Registration date
- 13/02/2007
- Last edited
- 13/02/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie
Ernst-Grube-Straße 40
Halle/Saale
06097
Germany
| ivar.friedrich@medizin.uni-halle.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | HYRISC |
| Study objectives | A decrease of postoperative rate of complications by hybrid-revascularisation is expected. |
| Ethics approval(s) | Ethics Committee of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg, approval received on 23/02/2005. |
| Health condition(s) or problem(s) studied | Multi-vessel coronary heart disease with diseased LAD requiring surgery |
| Intervention | 1. Hybrid group: surgical revascularisation of LAD with left Arteria thoracica interna-Bypass supply of dominant not interventional treatable vessels by off-pump technique. 2. Conventionally treated group: surgical revascularisation in cardioplegia by use of heart-lung machine. 3. Consecutive observed control group: surgical revascularisation in cardioplegia by use of heart-lung machine. |
| Intervention type | Other |
| Primary outcome measure(s) |
Occurrence of post-operative complications (organ insufficiencies, stroke, myocardial infarction, symptomatic transitory psychotic syndrome, infection, shock, multiple systems organ failure, death) during hospitalisation. |
| Key secondary outcome measure(s) |
1. Lethality and therapy costs during hospitalisation and in the first post-operative year |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 459 |
| Key inclusion criteria | 1. Coronary heart disease with diseased Left Anterior Descending coronary artery (LAD) requiring surgery 2. Male or female patients with 75 years of age or older in therapy groups 3. Male or female patients with 60 years of age or less in consecutive observed younger patients (control group) 4. Signed and dated informed consent |
| Key exclusion criteria | 1. Combined surgery (heart valve plus bypass) 2. Emergency treatment along with unstable cardiovascular system 3. Known intolerability of AcetylSalicylic acid (ASS), Clopidogrel and other concomitant medication required for stent-implantation 4. Participation on other clinical trials 5. Situations that limit the compliance with study requirements |
| Date of first enrolment | 10/06/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
06097
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 |
