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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 : Recruiting
First Posted : May 20, 2013
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):

Study Description
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
Myocardial Reperfusion Injury Procedure: Remote Ischaemic Conditioning

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Detailed Description:

Coronary heart disease (CHD) is the leading cause of death in Denmark and Europe, accounting for 1.92 million deaths in Europe per year: over one in five men (21%) and one in five women (22%) die from CHD.

Patients presenting with a ST-elevation Myocardial Infarction (STEMI)have despite advanced treatment with primary percutaneous coronary intervention (pPCI) a significant mortality and morbidity at one year with 17.4% of patients dying from a cardiovascular cause or being hospitalised from heart failure.

Remote Ischaemic Conditioning (RIC) applied at the time of myocardial reperfusion can reduce myocardial infarct size, confirming the existence of myocardial reperfusion injury. In this respect, RIC has been shown to limit myocardial infarct size and preserve cardiac function in STEMI patients undergoing pPCI.

RIC is performed in the ambulance during transport to the PCI unit by cycles of inflations of a blood pressure cuff to induce four 5-minute cycles of limb ischaemia and reperfusion. The method is virtually cost-free non-pharmacological and non-invasive therapeutic strategy.


RIC followed by pPCI improves clinical outcomes in STEMI patients when compared to STEMI controls undergoing standard pPCI evaluated one year post PCI.

Trial Design and aim:

Multinational investigator-driven, multi-centre, randomized, controlled, single-blind (Outcomes Assessor), parallel assignment, prospective clinical efficacy trial. A total of 2600 patients are to be included over a 36 months period.

Overall primary objective To determine whether RIC improves clinical outcomes (Cardiac mortality and hospitalisation for heart failure) at one year in 2600 STEMI patients undergoing pPCI.

Secondary objectives:

To determine, in the pre-specified subgroups, whether age, gender, diabetes, and duration of chest pain to PCI influence the response to RIC.

To determine whether RIC preserves left ventricular function measured by echocardiography after three months post pPCI.

Study progress The patient will be informed and treated according to the national and international guidelines for Good Clinical Practice and protected under the Act concerning the processing of personal data and health law.

The admitting ambulance doctor or doctor at the receiving hospital will orally inform the patient and hand out the approved short written information. After information is given in the acute phase the patient does not have much time for reflection before signing the informed consent form.

Therefore a full written information and additional oral information will be given to the patient after the acute phase by a study nurse or the doctor performing the pPCI. As well during the first and second stage of information it will be emphasised that the patient has the right to withdraw his/her informed consent at any time.

After informed consent is obtained the patient will be randomised via a secure web-site to either pPCI with or without RIC by the the doctor on duty at the receiving hospitals. Computer-generated blocked randomisation lists, stratified by centre, will be prepared in advance of the study.

pPCI incl. the use of stents and antithrombotic regimens will be performed according to standard procedures at the treating hospital.

Blood samples (acute, 6-8, 24 and 48-72 hours after pPCI will be drawn during the acute phase at the treating hospital or at the local hospital.

Three days after pPCI an echocardiography (ECCO) will be performed at the hospital. Further three months after pPCI an ECCO will be performed at the hospital.

Information regarding re-hospitalisation or death will be drawn from electronic patient chart.

Benefit of the study Potential benefits: Participating patients will be offered an extra clinical out patient control, incl. an echocardiography three months after pPCI.

Disadvantage: In relation to the inflation of the blood pressure cuff temporary moderate pains in the treated arm might occur. Otherwise, the RIC has previously been proven to be without side effects.

An extra blood sampling of app. 15 ml will be drawn 48-72 hours after pPCI. A small but insignificant risk of local infection in relation to this is a risk.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 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
Study Start Date : November 2013
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Eligibility Criteria

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

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

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

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   
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   
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
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 Posted: May 20, 2013    Key Record Dates
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