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

Heart Attack Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309994
• Other study ID #: 2019-02383; ch20Reuthebuch
• Status: Completed
• Start date: February 1, 2010
• Est. completion date: January 2020

Study information

• Verified date: March 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardioplegia Solution Adverse Reaction
• Coronary Artery Bypass Grafting (CABG)
• Heart Attack
• Infarction
• Myocardial Infarction

Intervention

Other:
• Myocardial protection system (MPS)
cardioplegia solution, A separate pumpsystem by which Blood cardioplegia with individually composable additives as cardioplegia solution can be used
• Cardioplexol
cardioplegia solution

Locations

Country	Name	City	State
Switzerland	Cardiac Surgery Clinic University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial damage	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)	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)
Secondary	30 days Mortality	death after coronary artery bypass grafting	30 days after CABG
Secondary	length of stay in the intensive care unit	duration of stay at intensive care unit	perioperative during hospital stay for CABG (for approximately 15 days)
Secondary	Number of participants with bleedings	bleeding complication after coronary artery bypass grafting	perioperative during hospital stay for CABG (for approximately 15 days)
Secondary	Number of participants with postoperative arrhythmia	rhythm disturbance after coronary artery bypass grafting	perioperative during hospital stay for CABG (for approximately 15 days)