HELIox CardiOPlegia Trial During Cardiac surgERy

C.Surgical Procedure; Cardiac Clinical Trial

— HELICOPTER-1  

Official title:

HELIox CardiOPlegia Trial During Cardiac surgERy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745951
• Other study ID #: 15 - 311
• 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

• C.Surgical Procedure; Cardiac

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