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OpenTrials
Completed

NCT Number: NCT04309994

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

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.

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Key information

Conditions

Heart Attack Cardioplegia Solution Adverse Reaction Cardiovascular Diseases Coronary Artery Bypass Grafting (CABG) Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiac Surgery Clinic University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myocardial protection system (MPS)

Other

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

Cardioplexol

Other

cardioplegia solution

Primary outcomes

  1. 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)

Secondary outcomes

  1. 30 days Mortality

    Time frame: 30 days after CABG

    death after coronary artery bypass grafting

  2. 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

  3. Number of participants with bleedings

    Time frame: perioperative during hospital stay for CABG (for approximately 15 days)

    bleeding complication after coronary artery bypass grafting

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Mar 17, 2020
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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