C.Surgical Procedure; Cardiac Clinical Trial
— HELICOPTER-1Official title:
HELIox CardiOPlegia Trial During Cardiac surgERy
The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of administering Heliox in cardioplegia during cardiac surgery and whether it has the potential to reduce the incidence and severity of myocardial ischemia during and after cardiac surgery.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | June 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 or older - Cardiac surgery with CPB where use of a coronary sinus catheter is indicated Exclusion Criteria: - Patient refusal - Recent myocardial infarction (less than 7 days old) - Left ventricular ejection fraction less than 30% - Known pregnancy on date of surgery |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of using Heliox to oxygenate the blood cardioplegia | To determine the feasibility of using Heliox to oxygenate the blood cardioplegia. Feasibility will be measured according to subject enrollment rates and to measurement of the blood gas content of the cardioplegia solutions. | 30 days from the intervention | No |
Secondary | New Myocardial Infarction | Myocardial infarction (MI) will be defined according to the Third Universal Definition of MI using the following two criteria: Serum levels of Troponin I: Values more than 10 times the 99th percentile of the upper limit from a normal baseline. If preoperative enzyme levels are abnormal, the post-operative enzymes must be greater than the baseline plus 10 times the upper limit from a normal baseline. ECG: At least one of the following i) New left bundle branch block ii) Development of new pathological Q waves iii) Imaging evidence of new loss of viable myocardium or new regional wall abnormality |
30 days from the intervention | Yes |
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