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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02745951
Other study ID # 15 - 311
Secondary ID
Status Recruiting
Phase N/A
First received April 18, 2016
Last updated May 2, 2016
Start date April 2016
Est. completion date June 2017

Study information

Verified date April 2016
Source St. Michael's Hospital, Toronto
Contact David Mazer, MD
Phone 416-864-5825
Email mazerd@smh.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


Description:

The HELICOPTER-1 Trial is a single centre, randomized trial evaluating the feasibility of administration of Heliox for prevention of myocardial ischemia in patients undergoing cardiac surgery. Half of the study population will be randomly assigned to the receive cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture, while the other half will be randomized to receive the current clinical standard of care (nitrogen and oxygen in cardioplegia).

Subjects will be followed up daily during their post-operative course in hospital for clinical outcomes. A 30-day phone follow-up will be conducted for vital status and MI.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Heliox
Half of the study population will be randomly assigned to receive cardioplegia enriched with a 70:30 (Helium:Oxygen) via a D100 pediatric oxygenator. The Heliox itself will need to be administered via an oxygen regulator using a low flowmeter.
Standard of care
The other half will be randomized to Nitrogen:Oxygen mixture. This will be done through the standard of care cardioplegia apparatus. There will be no novel interventions administered in this group.

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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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