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

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ClinicalTrials.gov Identifier: NCT01857414
Recruitment Status : Active, not recruiting
First Posted : May 20, 2013
Last Update Posted : June 18, 2018
Sponsor:
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 )

Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Reperfusion Injury Procedure: Remote Ischaemic Conditioning (RIC) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2613 participants
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
Actual Study Start Date : November 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Remote Ischaemic Conditioning
Use of Remote Ischaemic Conditioning prior to primary percutaneous coronary intervention
Procedure: Remote Ischaemic Conditioning (RIC)
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



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


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

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

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

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • Suspected 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)
  • Informed consent obtained
  • Life expectancy of more than 1 year

Exclusion Criteria:

  • Previous by-pass surgery
  • MI or treatment with thrombolysis within 30 days
  • New left bundle branch block
  • Patients treated with cooling
  • Paresis of upper limb
  • A-V shunt

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


Locations
Denmark
The Heart Centre, Aalborg Sygehus
Aalborg, Denmark, 9100
Department of Cardiology, Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200
The Heart Centre, Rigshospitalet, Copenhagen University
Copenhagen, Denmark, 2100
Department of Cardiology, Odense University Hospital
Odense, Denmark, 5000
Serbia
Military Medical Academy, Belgrade
Belgrade, Serbia, 11000
The Clinical Center of Serbia
Belgrade, Serbia, 11000
Spain
Hospital Universitario Central de Asturias
Oviedo, Spain, 33006
United Kingdom
The Hatter Cardiovascular Institute, University College London
London, United Kingdom, WC1E 6HX
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

Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01857414     History of Changes
Other Study ID Numbers: Condi2-37747
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: March 2018

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 Ischemia
Myocardial Infarction
Reperfusion Injury
ST Elevation Myocardial Infarction
Myocardial Reperfusion Injury
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
Pathologic Processes
Cardiomyopathies