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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list