Condition category
Circulatory System
Date applied
25/01/2006
Date assigned
25/09/2006
Last edited
25/09/2006
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

Prof Dag Sorlie

ORCID ID

Contact details

Breivika
Tromsoe
9038
Norway
+47 7762 6000
dag.sorlie@unn.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Nicorandil instead of supranormal potassium in cardioplegia is feasible, providing cardiac arrest and protection.

Ethics approval

Helse Nord research fund.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Angina pectoris

Intervention

Two groups of cardioplegia randomised to receive either:

1. Standard St. Thomas Hospital Solution (high [16 mM] potassium cardioplegia)
2. Nicorandil

Intervention type

Drug

Phase

Not Specified

Drug names

Nicorandil

Primary outcome measures

1. Creatine Kinase Myocardial Band (CKMB)
2. Troponin
3. Cardiac Index (CI)
4. Saphenous Vein (SV)
5. Systemic Vascular Resistance (SVR)
6. Heart rate (HR)
7. Time to arrest

Secondary outcome measures

Quality of life

Overall trial start date

24/01/2005

Overall trial end date

26/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 40 to 75 years
2. Elective to Coronary Artery Bypass Graft (CABG)
3. Ejection Fraction (EF) more than 40%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Concomitant procedures
2. Emergency procedures
3. Glibenclamid medication
4. Pregnancy

Recruitment start date

24/01/2005

Recruitment end date

26/09/2005

Locations

Countries of recruitment

Norway

Trial participating centre

Breivika
Tromsoe
9038
Norway

Sponsor information

Organisation

University Hospital of North Norway (Norway)

Sponsor details

Breivika
Tromsoe
9038
Norway
+47 7762 6000
dag.sorlie@unn.no

Sponsor type

University/education

Website

http://www.unn.no/

Funders

Funder type

Government

Funder name

Local Health Authorities

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Hospital of North Norway

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