Clinical Trials Logo
  1. Home
  2. Myocardial Injury
  3. NCT04436016

PeRiOperaTivE CardioproTection With Ivabradine in Non-cardiac Surgery — PROTECTIN  

Myocardial Ischemia Clinical Trial

Official title:
Effect of Heart Rate Control With Ivabradine on Myocardial Injury After Non-cardiac Surgery: a Single Center, Randomized Controlled, Double-blind Feasibility Pilot Trial

Clinical Trial Summary

Perioperative myocardial injury (PMI) after non-cardiac surgery (NCS), i.e. the elevation of postoperative troponin, occurs in nearly 20% of patients older than 45 years undergoing NCS and is independently and strongly associated with post-operative mortality (30-day mortality up to 10%). With over 300 million surgical interventions every year worldwide, PMI has a high clinical relevance on the health of the population. Heart rate (HR) is an independent and modifiable risk factor for PMI and death after non-cardiac surgery. Numerous studies showed that beta-blockers decrease myocardial ischemia after surgery in a heart-rate dependent manner, but this beneficial effect is surpassed by an increased incidence of perioperative hypotension and death. Currently, no single intervention is available to decrease the risk of perioperative cardiac complications. Ivabradine (IVA) is a negative chronotropic agent without significant effects on contractility or vascular tone and has been shown to improve outcomes in the setting of chronic and acute heart diseases. Rationale for pilot feasibility trial: the planned definitive large trial is a multicenter trial to investigate the efficacy of ivabradine to decrease perioperative myocardial injury. The intervention planned is complex and demands important resources. The investigators designed this pilot study to inform on the feasibility of the definitive large trial. This pilot study will also provide additional information that could help investigators improve the definitive large trial regarding recruitment, refinements to the study protocol and improving the participant's experience.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04436016
Study type Interventional
Source University Hospital, Geneva
Contact
Status Completed
Phase Phase 4
Start date October 5, 2020
Completion date January 11, 2022
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Completed NCT04153006 - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed NCT01205776 - EXCEL Clinical Trial N/A
Active, not recruiting NCT04555174 - BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
Recruiting NCT04582877 - Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial N/A
Recruiting NCT04390672 - Multivessel TALENT N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
Not yet recruiting NCT04522583 - Increased CRP Concentrations in Patients Admitted to the Emergency Department With Troponin Elevation Aids to Rule Out Coronary Ischemia
Completed NCT02510547 - Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial Phase 4
Terminated NCT02407626 - Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery N/A
Completed NCT02554006 - Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings N/A
Active, not recruiting NCT02189499 - Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent Phase 2
Completed NCT02264717 - Dan-NICAD - Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease N/A
Completed NCT02197065 - Pilot Study of Atorvastatin for Orthopedic Surgery Patients Phase 2
Recruiting NCT01681381 - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization N/A
Completed NCT01679886 - Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women N/A
Terminated NCT01892917 - BIOFLOW-III Hungary Satellite Registry N/A
Completed NCT01655043 - Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI Phase 2
Completed NCT02707445 - Genotyping Influences Outcome of Coronary Artery Stenting N/A