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ISRCTN
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ISRCTN53284852
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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HYRISC
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Serial number at source
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KKSH-018/1
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Study hypothesis
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A decrease of postoperative rate of complications by hybrid-revascularisation is expected.
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Lay summary
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Ethics approval
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Ethics Committee of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg, approval received on 23/02/2005.
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Study design
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Open-label, randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Multi-vessel coronary heart disease with diseased LAD requiring surgery
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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10/06/2005
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Anticipated end date
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30/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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459
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Interventions
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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.
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Primary outcome measure(s)
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Occurrence of post-operative complications (organ insufficiencies, stroke, myocardial infarction, symptomatic transitory psychotic syndrome, infection, shock, multiple systems organ failure, death) during hospitalisation.
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Secondary outcome measure(s)
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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)
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Sources of funding
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Self-funded by the Department of Cardiothoracic Surgery and Cardiology, Martin-Luther-University Halle (Germany)
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Trial website
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Publications
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Contact name
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Dr
Ivar
Friedrich
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Address
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Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie
Ernst-Grube-Straße 40
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City/town
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Halle/Saale
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Zip/Postcode
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06097
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Country
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Germany
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Email
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ivar.friedrich@medizin.uni-halle.de
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Sponsor
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Martin Luther-University Halle-Wittenberg (Germany)
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Address
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Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie
Ernst-Grube-Straße 40
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City/town
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Halle/Saale
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Zip/Postcode
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06097
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Country
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Germany
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Email
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ivar.friedrich@medizin.uni-halle.de
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Sponsor website:
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http://www2.uni-halle.de/index_e.htm
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Date applied
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05/01/2007
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Last edited
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13/02/2007
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Date ISRCTN assigned
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13/02/2007
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