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OpenTrials
Completed

NCT Number: NCT01740102

Clinical Value of Remote Ischemic Preconditioning

Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).

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Key information

Conditions

Heart Diseases Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital Trondheim University Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective isolated on-pump CABG surgery
  • Informed consent

Exclusion criteria

  • Patients with a severe pulmonary disease
  • Patients with renal failure (GFR<30 mL/min/1.73 m2)
  • Patients with liver failure
  • Peripheral vascular disease affecting the upper limbs
  • Patients on sulfonylurea derivatives.
  • Patients with atrial fibrillation in their case history
  • Prior cardiac surgery (Re-operations)

Treatment and study plan

RIPC

Procedure

The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes.

Other names: Remote ischemic preconditioning, Ischemic preconditioning

Primary outcomes

  1. Postoperative atrial fibrillation

    Time frame: Up to 10 days after surgery

    A patient will be classified as belonging to the postoperative atrial fibrillation group if they have any episode of atrial fibrillation, measured by telemetry, lasting more than 1 minute during their postoperative days at the hospital.

Secondary outcomes

  1. Length of hospital stay

    Time frame: Maximum 14 days

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Helse Møre og Romsdal HF
  • Helse Nord-Trøndelag HF
  • Namsos Hospital
  • Sykehuset Innlandet HF

Registry information

Official study title

Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 4, 2012
Registry last updated
Aug 4, 2016

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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