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

NCT04309994 | Completed

• 1 other identifier: 2019-02383; ch20Reuthebuch
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Attack; Cardioplegia Solution Adverse Reaction; Coronary Artery Bypass Grafting (CABG)

Keywords

heart attack; cardioplegia solution; Minimal extracorporeal circulation system (MiECC); Myocardial protection system (MPS); Coronary artery bypass grafting (CABG)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 30 days Mortality

  30 days after CABG

• length of stay in the intensive care unit

  perioperative during hospital stay for CABG (for approximately 15 days)

• Number of participants with bleedings

  perioperative during hospital stay for CABG (for approximately 15 days)

• Number of participants with postoperative arrhythmia

  perioperative during hospital stay for CABG (for approximately 15 days)

Study Arms (2)

Experimental

bypass surgery with blood cardioplegia by means of MPS

Other: Myocardial protection system (MPS)

Active Comparator

bypass surgery with blood cardioplegia by means of Cardioplexol ®

Other: Cardioplexol

Interventions

Myocardial protection system (MPS) OTHER

cardioplegia solution, A separate pumpsystem by which Blood cardioplegia with individually composable additives as cardioplegia solution can be used

Experimental

Cardioplexol OTHER

cardioplegia solution

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients which underwent isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Cardiac Surgery Clinic University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Oliver Reuthebuch, Prof. Dr. med.

  Cardiac Surgery Clinic, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 17, 2020
• Study Start: February 1, 2010
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

CH (1)