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

March 16, 2020 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Cardiac Surgery Clinic University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
bypass surgery with blood cardioplegia by means of MPS
Other: Myocardial protection system (MPS)
cardioplegia solution, A separate pumpsystem by which Blood cardioplegia with individually composable additives as cardioplegia solution can be used
Active Comparator
bypass surgery with blood cardioplegia by means of Cardioplexol ®
Other: Cardioplexol
cardioplegia solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial damage
Time Frame: 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)
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Oliver Reuthebuch, Prof. Dr. med., Cardiac Surgery Clinic, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-02383; ch20Reuthebuch

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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