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
Secondary identifying numbers	KKSH-018/1

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

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

Dr Ivar Friedrich
Scientific

Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie
Ernst-Grube-Straße 40
Halle/Saale
06097
Germany

Email	ivar.friedrich@medizin.uni-halle.de

Study information

Study design	Open-label, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	10/06/2005
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	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

Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie

Halle/Saale
06097
Germany

Sponsor information

Martin Luther-University Halle-Wittenberg (Germany)
Hospital/treatment centre

Universitätsklinik und Poliklinik für Herz- und Thoraxchirurgie
Ernst-Grube-Straße 40
Halle/Saale
06097
Germany

Email	ivar.friedrich@medizin.uni-halle.de
Website	http://www2.uni-halle.de/index_e.htm
"ROR"	https://ror.org/05gqaka33

Funders

Funder type

Hospital/treatment centre

Self-funded by the Department of Cardiothoracic Surgery and Cardiology, Martin-Luther-University Halle (Germany)

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