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
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.
n/a
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 |
NCT02197065 -
Pilot Study of Atorvastatin for Orthopedic Surgery Patients
|
Phase 2 | |
Completed |
NCT02264717 -
Dan-NICAD - Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease
|
N/A | |
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 |