Contact information
Type
Scientific
Primary contact
Dr Ivar Friedrich
ORCID ID
Contact details
Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie
Ernst-Grube-Straße 40
Halle/Saale
06097
Germany
ivar.friedrich@medizin.uni-halle.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KKSH-018/1
Study information
Scientific title
Acronym
HYRISC
Study hypothesis
A decrease of postoperative rate of complications by hybrid-revascularisation is expected.
Ethics approval
Ethics Committee of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg, approval received on 23/02/2005.
Study design
Open-label, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Occurrence of post-operative complications (organ insufficiencies, stroke, myocardial infarction, symptomatic transitory psychotic syndrome, infection, shock, multiple systems organ failure, death) during hospitalisation.
Secondary outcome measures
1. Lethality and therapy costs during hospitalisation and in the first post-operative year
2. Survival after six and 12 month
3. Rates of complications (see primary outcomes)
4. Post-operative quality of life (Short Form health survey [SF-36], Hospital Anxiety and Depression Scale [HADS])
5. Occurrence of postoperative complications in the group of consecutive observed younger patients (control group)
Overall trial start date
10/06/2005
Overall trial end date
30/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
459
Participant 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
Recruitment start date
10/06/2005
Recruitment end date
30/09/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie
Halle/Saale
06097
Germany
Sponsor information
Organisation
Martin Luther-University Halle-Wittenberg (Germany)
Sponsor details
Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie
Ernst-Grube-Straße 40
Halle/Saale
06097
Germany
ivar.friedrich@medizin.uni-halle.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Self-funded by the Department of Cardiothoracic Surgery and Cardiology, Martin-Luther-University Halle (Germany)
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
Basic results (scientific)
Publication list