The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

NCT03305094 | Unknown

• 1 other identifier: CONDOR-21082
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery.

Conditions

Aortic Valve Stenosis; Cardiopulmonary Bypass

Keywords

Remote ischemic preconditioning; Myocardial infarction; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Change in biochemical markers of myocardial ischemia

  Troponin T-HS and CK-MB concentration

  6, 12, 24 and 48 hours post-operatively

Secondary Outcomes (1)

• Post-operative complications

  post-operatively until 30 days

Study Arms (2)

Control group

ACTIVE COMPARATOR

Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass. A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia.

Procedure: Blood pressure cuff inflation

Intervention group

EXPERIMENTAL

Remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass.

Procedure: Blood pressure cuff inflation

Interventions

Blood pressure cuff inflation PROCEDURE

Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned isolated aortic valve replacement (stenosis based)
• Age ≥ 18 years

You may not qualify if:

• Pregnancy
• Left ventricular dysfunction (LVEF\< 50%)
• Myocardial Infarct (\< 7days)
• Coronary artery disease (documented with \>50% stenosis)
• Coronary artery bypass grafting
• Chronic renal insufficiency (creatinine \>175 mmol/L or dialysis)
• Endocarditis
• Sternotomy redo
• Deep vein thrombosis to the compressed limb
• Emergency procedure
• TAVI procedure
• Planned off pump coronary artery bypass
• MAZE procedure

Sponsors & Collaborators

• Laval University: lead
• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: collaborator

Study Sites (1)

Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Myocardial Infarction

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Pierre Voisine, MD

  University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac surgeon

Model Details: Randomized controlled prospective trial

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 9, 2017
• Study Start: April 11, 2014
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)