Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04436016
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2020-06-10
Brief Title:
PeRiOperaTivE CardioproTection With Ivabradine in Non-cardiac Surgery
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECTIN
Brief Summary:
Perioperative myocardial injury PMI after non-cardiac surgery NCS ie 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 participants experience
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 participants experience
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SNCTP000003728 | REGISTRY | Swiss Federal Office of Public Healths portal for human research | None |