The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03305094

Enrollment

140

Registered

2017-10-09

Start date

2014-04-11

Completion date

2024-12-01

Last updated

2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Cardiopulmonary Bypass

Keywords

Remote ischemic preconditioning, Myocardial infarction, Cardiac surgery

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.

Interventions

PROCEDUREBlood pressure cuff inflation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Participant is blinded to group assignment

Intervention model description

Randomized controlled prospective trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change in biochemical markers of myocardial ischemia	6, 12, 24 and 48 hours post-operatively	Troponin T-HS and CK-MB concentration

Secondary

Measure	Time frame	Description
Post-operative complications	post-operatively until 30 days	Monitoring the safety of the strategy by monitoring post-operative complications

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026