Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)

Not Applicable

Completed

• Conditions: STEMI; Myocardial Reperfusion Injury

• Registration Number: NCT02342522
• Lead Sponsor: University College, London

Brief Summary

The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.

Detailed Description

The CONDI2/ERIC-PPCI trial is a randomised controlled clinical trial investigating whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in 5400 patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI).

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-21
• Status Verified: 2018-10
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5413

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rates of cardiac death and hospitalization for heart failure (HHF) at 1 year.	One year

Secondary Outcome Measures

Name	Time	Method
Rates of cardiac death and HHF at 30 days.	30 days
Rates of all-cause death, repeat coronary revascularisation, reinfarction, stroke at 30 days and 12 months.	12 months
TIMI flow post-PPCI.	1 week
Quality of life at 6-8 weeks and 12 months (EuroQol EQ-5D-5L).	One year
Biomarkers substudy: Enzymatic infarct size - 48 hour area-under-the-curve (AUC) cardiac biomarkers	1 week
CMR substudy: Cardiac MRI in first week and at 6 months	6 months

Trial Locations

Locations (35)

Prehospital Emergency Medical Service, North Denmark Region; 🇩🇰 Aalborg, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Prehospital Emergency Medical Service, Central Denmark Region; 🇩🇰 Aarhus, Denmark

Prehospital Emergency Medical Service, Region Zealand; 🇩🇰 Ballerup, Denmark

Rigshospitalet; 🇩🇰 København, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Prehospital Emergency Medical Service , South Denmark Region; 🇩🇰 Vejle, Denmark

Clinical Centre of Serbia; 🇷🇸 Belgrade, Serbia

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Royal Sussex County Hospital; 🇬🇧 Brighton, Sussex, United Kingdom

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