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 Universityhospital
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

May 15, 2013
August 7, 2014
November 2013
December 2016   (final data collection date for primary outcome measure)
Cardiovascular mortality [ Time Frame: One year ] [ Designated as safety issue: No ]
Cardiovascular mortality and hospitalisation for heart failure at one year
Same as current
Complete list of historical versions of study NCT01857414 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effect of RIC on Clinical Outcomes in STEMI Patients Undergoing pPCI
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Myocardial Reperfusion Injury
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.
  • Experimental: Remote Ischaemic Conditioning
    Use of Remote Ischaemic Conditioning prior to primary percutaneous coronary intervention
    Intervention: Procedure: Remote Ischaemic Conditioning
  • No Intervention: No use of Remote Ischaemic Conditioning
    No use of Remote Ischaemic Conditioning prior to percutaneous coronary intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2300
Not Provided
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Hans Erik Bøtker, Professor heb@dadlnet.dk
Contact: Kristine M Liendgaard, Adjunct kristine.moller@ki.au.dk
Denmark,   Serbia,   Spain,   United Kingdom
 
NCT01857414
Condi2-37747
No
University of Aarhus ( Aarhus University Hospital )
Aarhus University Hospital
  • Rigshospitalet, Denmark
  • Aalborg Universityhospital
  • 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
Principal Investigator: Hans Erik Bøtker, Professor Aarhus University Hospital
University of Aarhus
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP