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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Aarhus
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Aalborg Universitetshospital
Odense University Hospital
Hospital Universitario Central de Asturias
Clinical Centre of Serbia
The Military Medical Academy, Belgrade, Serbia
The Hatter Cardiovascular Institute, London W, United Kingdom
Central Denmark Region
Prehospital Emergency Medical Service, The 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 )
ClinicalTrials.gov Identifier:
NCT01857414
First received: May 15, 2013
Last updated: August 7, 2014
Last verified: August 2013
  Purpose

The aim of the the study is to investigate whether Remote Ischaemic Conditioning (RIC) can improve clinical outcomes (cardiovascular 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 Phase
Myocardial Reperfusion Injury
Procedure: Remote Ischaemic Conditioning
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

Primary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: One year ] [ Designated as safety issue: No ]
    Cardiovascular mortality and hospitalisation for heart failure at one year


Secondary Outcome Measures:
  • Myocardial infarct size [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Myocardial infarct size at day 3 (72 hours area under curve serum troponin T)

  • Left ventricular function [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Left ventricular function on day three and three months post pPCI (Echocardiography)

  • Prognosis [ Time Frame: One year ] [ Designated as safety issue: No ]
    Re-infarction, stroke and revascularisation at one year


Estimated Enrollment: 2300
Study Start Date: November 2013
Estimated Primary Completion Date: December 2016 (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 right upper arm and inflated to 200 mmHg for 5 minutes and then deflated for 5 minutes, a programmed cycle which is repeated 4 times in total (therefore the total length of the RIC protocol is 40 minutes). If the initial systolic blood pressure is >175 mmHg, the cuff will be inflated to 25 mmHg above the systolic blood pressure. 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

  Hide Detailed Description

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.

Hypothesis:

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 2300 patients are to be included over a 36 months period.

Overall primary objective To determine whether RIC improves clinical outcomes (Cardiovascular mortality and hospitalisation for heart failure) at one year in 2300 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 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 72 hours after pPCI. A small but insignificant risk of local infection in relation to this is a risk.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 Life expectancy of more than 1 year

Exclusion Criteria:

  • Previous by-pass surgery
  • MI or treatment with thrombolysis within 30 days
  • Patients treated with cooling
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857414

Contacts
Contact: Hans Erik Bøtker, Professor heb@dadlnet.dk
Contact: Kristine M Liendgaard, Adjunct kristine.moller@ki.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       kristine.moller@ki.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 Not yet 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 Not yet 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
The Military Medical Academy, Belgrade, Serbia
The Hatter Cardiovascular Institute, London W, United Kingdom
Central Denmark Region
Prehospital Emergency Medical Service, The 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

No publications provided

Responsible Party: University of Aarhus ( Aarhus University Hospital )
ClinicalTrials.gov Identifier: NCT01857414     History of Changes
Other Study ID Numbers: Condi2-37747
Study First Received: May 15, 2013
Last Updated: August 7, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on October 23, 2014