Evidence map›Paper›PMID 38887884›Full record

Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2024

A randomised trial of selective intracoronary hypothermia during primary PCI.

Mohamed El Farissi, Nico H J Pijls, Richard Good, Thomas Engström, Thomas R Keeble, Branko Beleslin, Bernard De Bruyne, Ole Fröbert, David Erlinge, Koen Teeuwen and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03447834 (Selective Intracoronary Hypothermia in Patients With ST-elevation Myocardial Infarction to Reduce Infarct Size), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03447834 naunknown statusnot on this map

Selective Intracoronary Hypothermia in Patients With ST-elevation Myocardial Infarction to Reduce Infarct Size

TypeinterventionalSponsorCatharina Ziekenhuis EindhovenRan2019 to 2023Enrolled200ConditionsAcute Myocardial Infarction, Reperfusion InjuryArmsSelective intracoronary hypothermia + PPCI, Standard PPCI
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Impact of Mild Hypothermia As Adjunctive Therapy in Patients With ST-Elevation Myocardial Infarction: A Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Impact of intracoronary supersaturated oxygen therapy on microvascular obstruction and infarct size in patients with acute anterior myocardial infarction.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
  6. Review
  7. Therapeutic hypothermia to reduce infarct size in STEMI: time to give it the cold shoulder?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Mohamed El FarissiDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Nico H J PijlsDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Richard GoodDepartment of Cardiology, Golden Jubilee National Hospital, Clydebank, United Kingdom.
Thomas EngströmDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Thomas R KeebleDepartment of Cardiology, Essex Cardiothoracic Centre, Basildon, United Kingdom.
Branko BeleslinDepartment of Cardiology, Clinical Center of Serbia, Belgrade, Serbia.
Bernard De BruyneCardiovascular Center Aalst, OLV Clinic, Aalst, Belgium.
Ole FröbertÖrebro University, Faculty of Health, Department of Cardiology, Örebro, Sweden.
David ErlingeDepartment of Cardiology, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.
Koen TeeuwenDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Rob EerdekensDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Jesse P A DemandtDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Kenneth MangionDepartment of Cardiology, Golden Jubilee National Hospital, Clydebank, United Kingdom.
Jakob LonborgDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Wikke Setz-PelsDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Grigoris KaramasisDepartment of Cardiology, Essex Cardiothoracic Centre, Basildon, United Kingdom.
Inge WijnbergenDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Pieter Jan VlaarDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Annemiek de VosDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Guus R BruerenDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Keith OldroydDepartment of Cardiology, Golden Jubilee National Hospital, Clydebank, United Kingdom.
Colin BerryDepartment of Cardiology, Golden Jubilee National Hospital, Clydebank, United Kingdom.
Pim A L ToninoDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Marcel Van't VeerDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
Luuk C OtterspoorDepartment of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking.

aimsWe investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI.

methodsIn this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to the occlusion was selectively cooled to 30-33°C for 7-10 minutes before reperfusion (occlusion phase), immediately followed by 10 minutes of cooling after reperfusion (reperfusion phase). The primary endpoint was infarct size as a percentage of left ventricular mass on cardiovascular magnetic resonance imaging after 3 months.

resultsSelective intracoronary hypothermia was performed in 94/100 patients randomised to cooling. Distal coronary temperature decreased by 6°C within 43 seconds (interquartile range [IQR] 18-113). The median duration of the occlusion phase and reperfusion phase were 8.2 minutes (IQR 7.2-9.0) and 9.1 minutes (IQR 8.2-10.0), respectively. The infarct size at 3 months was 23.1±12.5% in the selective intracoronary hypothermia group and 21.6±12.2% in the primary PCI alone group (p=0.43). The left ventricular ejection fraction at 3 months in each group were 49.1±10.2% and 50.1±10.4%, respectively (p=0.53).

conclusionsSelective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI was feasible and safe but did not decrease infarct size compared with standard primary PCI. (ClinicalTrials.gov: NCT03447834).

Indexed as

Hypothermia, InducedPercutaneous Coronary InterventionST Elevation Myocardial InfarctionAgedFemaleHumansMaleMiddle AgedTreatment Outcome

Identifiers

PMID38887884
PMCPMC11165355

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.