Condition category
Circulatory System
Date applied
05/01/2007
Date assigned
13/02/2007
Last edited
13/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www2.uni-halle.de/index_e.htm

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes