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Effect of RIC on Clinical Outcomes in STEMI Patients Undergoing pPCI (CONDI2)

This study is currently recruiting participants.
Verified October 2016 by University of Aarhus ( Aarhus University Hospital )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01857414
First Posted: May 20, 2013
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Rigshospitalet, Denmark
Aalborg Universitetshospital
Odense University Hospital
Hospital Universitario Central de Asturias
Clinical Centre of Serbia
Military Medical Academy, Belgrade, Serbia
The Hatter Cardiovascular Institute, London W, United Kingdom
Central Denmark Region
Region of Southern Denmark
Prehospital Emergency Medical Service, The North Denmark Region
Region Zealand
The Danish Medical Research Council
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )
  Purpose
The aim of the the study is to investigate whether Remote Ischaemic Conditioning (RIC) can improve clinical outcomes (cardiac death and hospitalisation for heart failure) at one year in patients presenting with ST-elevation Myocardial Infarction and undergoing primary percutaneous coronary intervention. This will be done in a multinational investigator-driven, multi-centre, randomised, controlled, single-blind, parallel assignment, prospective clinical efficacy trial.

Condition Intervention
Myocardial Reperfusion Injury Procedure: Remote Ischaemic Conditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Remote Ischaemic Conditioning on Clinical Outcomes in ST-elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Multinational Multicentre Randomised Controlled Clinical Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus ( Aarhus University Hospital ):

Primary Outcome Measures:
  • Cardiac mortality [ Time Frame: One year ]
    Cardiac mortality and hospitalisation for heart failure at one year


Secondary Outcome Measures:
  • Myocardial infarct size [ Time Frame: 72 hours ]
    Myocardial infarct size at day 3 (72 hours area under curve serum troponin T)

  • Left ventricular function [ Time Frame: Three months ]
    Left ventricular function on day three and three months post pPCI (Echocardiography)

  • Prognosis [ Time Frame: One year ]
    Re-infarction, stroke and revascularisation at one year

  • Acute kidney injury [ Time Frame: 48-72 hours ]
    Changes in Serum Creatinine


Estimated Enrollment: 2600
Study Start Date: November 2013
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote Ischaemic Conditioning
Use of Remote Ischaemic Conditioning prior to primary percutaneous coronary intervention
Procedure: Remote Ischaemic Conditioning
The CellAegis auto RIC (automated blood pressure cuff) will be placed on the upper arm and inflate to 200 mmHg for 5 minutes followed by 5 minutes of deflations. The programmed cycle is repeated 4 times in total, summing up to a total treatment length of 35 minutes).In recruiting centres where randomisation occurs at the hospital or in cases with short transportation time, the RIC protocol will continue during PCI until successful or until immediately before reperfusion.
No Intervention: No use of Remote Ischaemic Conditioning
No use of Remote Ischaemic Conditioning prior to percutaneous coronary intervention

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients (>18 years old) presenting with chest pain for more than 30 minutes
  • Putative STEMI (ST-elevation at the J-point in two contiguous leads with the cut-off points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/ or ≥0.1 mV in other leads)
  • New left bundle branch block who are eligible for pPCI (chest pain onset <12 hours)
  • Informed consent obtained

Exclusion Criteria:

  • Previous by-pass surgery
  • MI or treatment with thrombolysis within 30 days
  • Patients treated with cooling
  • Paresis of upper limb
  • A-V shunt
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857414


Contacts
Contact: Hans Erik Bøtker, Professor heb@dadlnet.dk
Contact: Kristine M Liendgaard, Adjunct k.moller@clin.au.dk

Locations
Denmark
The Heart Centre, Aalborg Sygehus Recruiting
Aalborg, Denmark, 9100
Contact: Søren Hjortshøj, Consultant       sph@rn.dk   
Department of Cardiology, Aarhus University Hospital, Skejby Recruiting
Aarhus, Denmark, 8200
Contact: Hans Erik Bøtker, Professor       HEB@dadlnet.dk   
Contact: Kristine M Liendgaard, Adjunct       k.moller@clin.au.dk   
The Heart Centre, Rigshospitalet, Copenhagen University Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Thomas Engstrøm, Consultant       Thomas.engstroem@rh.regionh.dk   
Department of Cardiology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Lissette O Jensen, Lecturer       okkels@dadlnet.dk   
Serbia
Military Medical Academy, Belgrade Not yet recruiting
Belgrade, Serbia, 11000
Contact: Slobodan Obradovic, Professor       sloba.d.obradovic@gmail.com   
The Clinical Center of Serbia Not yet recruiting
Belgrade, Serbia, 11000
Contact: Dejan Milasinovic, Professor       d.mil8412@gmail.com   
Contact: Goran Stankovic, Professor       gorastan@sbb.rs   
Spain
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain, 33006
Contact: José MG Ruiz, Group leader       josemanuel.garcia@externo.cnic.es   
United Kingdom
The Hatter Cardiovascular Institute, University College London Recruiting
London, United Kingdom, WC1E 6HX
Contact: Derek Hausenloy, Scientist       d.hausenloy@ucl.ac.uk   
Sponsors and Collaborators
Aarhus University Hospital
Rigshospitalet, Denmark
Aalborg Universitetshospital
Odense University Hospital
Hospital Universitario Central de Asturias
Clinical Centre of Serbia
Military Medical Academy, Belgrade, Serbia
The Hatter Cardiovascular Institute, London W, United Kingdom
Central Denmark Region
Region of Southern Denmark
Prehospital Emergency Medical Service, The North Denmark Region
Region Zealand
The Danish Medical Research Council
Investigators
Principal Investigator: Hans Erik Bøtker, Professor Aarhus University Hospital
  More Information

Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01857414     History of Changes
Other Study ID Numbers: Condi2-37747
First Submitted: May 15, 2013
First Posted: May 20, 2013
Last Update Posted: October 25, 2017
Last Verified: October 2016

Keywords provided by University of Aarhus ( Aarhus University Hospital ):
ST-elevation myocardial infarction
Remote Ischaemic Conditioning
Myocardial Reperfusion Injury
Cardiovascular mortality

Additional relevant MeSH terms:
Myocardial Infarction
Reperfusion Injury
ST Elevation Myocardial Infarction
Myocardial Reperfusion Injury
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Pathologic Processes
Cardiomyopathies