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Completed

NCT Number: NCT02021760

Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction

* Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI. * Trial Design: Placebo controlled randomized study with parallel groups * Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7 * Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months. * Global left ventricular function determined by left ventricular ejection fraction determined by CMR. * Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180. * Safety Parameters: Major adverse cardiovascular events.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease 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

Interventional

Phase

Not applicable

Primary location

Danderyds Hospital, Stockholm, Sweden

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About this study

See above. 3 patients left to include.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient planned for primary PCI.
  • Chest pain indicating myocardial ischemia with a duration >30 minutes and < 6 hours prior to randomization.
  • ST elevations >0.1 mV (>0.2 mV in V2-V3) in > two contiguous leads in V1-V6.
  • Informed consent.

Exclusion criteria

  • Previous myocardial infarction based on medical history or Q-wave on ECG in other area
  • Left Bundle Branch Block on ECG.
  • Previous CABG
  • Cardiac arrest
  • Any contraindication for CMR.
  • Clinical symptoms of claudication
  • Treatment with glibenclamide or cyclosporine on admission.
  • Any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.

Treatment and study plan

Primary percutaneous coronary intervention

Procedure

Primary Percutanous Coronary Intervention is performed in both Groups.

Primary outcomes

  1. Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance

    Time frame: 4-7 days following index event

Secondary outcomes

  1. Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance

    Time frame: 6 months following index event

Other outcomes

  1. Global left ventricular function determined by left ventricular ejection fraction determined by CMR.

    Time frame: 4-7 days and 6 months following index event

  2. Microvascular obstruction determined by CMR

    Time frame: 4-7 days following index event

  3. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk

    Time frame: 4-7 days following index event

  4. Myocardial infarct size by CMR expressed as a percentage to the myocardium at risk determined by Bari or modified Approach Score with coronary angiography.

    Time frame: 5-7 days following index event

Sponsors and collaborators

Lead sponsor

John Pernow

Other

Registry information

Official study title

Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)

Acronym: RECOND

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 27, 2013
Registry last updated
Feb 9, 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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