Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction

Completed

• Conditions: Heart Attack; Cardioplegia Solution Adverse Reaction; Coronary Artery Bypass Grafting (CABG)
• Interventions: Other: Cardioplexol; Other: Myocardial protection system (MPS)

• Registration Number: NCT04309994
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The goal of this study is to compare the two cardioplegia solutions (blood cardioplegia by means of MPS ® vs. Cardioplexol ®) regarding perioperative outcome and with special attention to cardiac markers in patients with a recent heart attack.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-16
• Last Update Submitted: 2020-03-16
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

• Patients who underwent a CABG using MPS® or Cardioplexol ®
• Heart attack less than 7 days before surgery

Exclusion Criteria

• use of other cardioplegia solution than Cardioplexol ® or MPS®
• other inventions than CABG
• explicit will of the patient that his data may not be used
• denied general consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active Comparator	Cardioplexol	bypass surgery with blood cardioplegia by means of Cardioplexol ®
Experimental	Myocardial protection system (MPS)	bypass surgery with blood cardioplegia by means of MPS

Primary Outcome Measures

Name	Time	Method
myocardial damage	patients with that received a coronary artery bypass grafting and that were treated (for approximately 15 days) at the University Hospital between February 2010 and January 2020 (data taken perioperative during hospital stay for CABG)	Analyse cardiac biomarkers as indicators for myocardial damage: high sensitive troponin (Ths-TrT, ng/mL), creatine kinase (CK, in ng/mL) and creatine kinase-MB isoenzyme (CK-MB, in ng/mL)

Secondary Outcome Measures

Name	Time	Method
30 days Mortality	30 days after CABG	death after coronary artery bypass grafting
length of stay in the intensive care unit	perioperative during hospital stay for CABG (for approximately 15 days)	duration of stay at intensive care unit
Number of participants with bleedings	perioperative during hospital stay for CABG (for approximately 15 days)	bleeding complication after coronary artery bypass grafting
Number of participants with postoperative arrhythmia	perioperative during hospital stay for CABG (for approximately 15 days)	rhythm disturbance after coronary artery bypass grafting

Trial Locations

Locations (1)

Cardiac Surgery Clinic University Hospital Basel; 🇨🇭 Basel, Switzerland