Trans-coronary Cooling and Dilution for Cardioprotection During Revascularisation for ST-elevation Myocardial Infarction

NCT06128993 | Recruiting DMC

• 1 other identifier: 315559
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A heart attack (myocardial infarction) occurs when an artery supplying blood to the heart is suddenly blocked resulting in damage to the heart muscle. Patients presenting to hospital with a heart attack undergo an immediate angiogram (x-ray of the arteries in the heart) and are usually treated immediately with a balloon and stent to open their blocked artery. This procedure is called "primary percutaneous coronary intervention" (or primary PCI for short). An angiogram is a routine procedure that involves insertion of fine plastic tube (catheter) into either the groin or wrist under local anaesthetic. The tube is passed into the artery in the heart and X-ray pictures are taken to find out if the arteries are blocked. Blocked arteries can usually be opened by passing a small balloon into the artery, via the fine plastic tube followed by placement of a stent (a fine metal coil) into the artery to prevent it from blocking again. Although this treatment is very successful, it can result in damage to the heart muscle when the artery is opened. Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in some patients but not in others; however, it is uncomfortable due to the shivering, expensive and can result in delays in opening the blocked artery. The investigators are conducting a series of research studies to find out if cooling the heart muscle directly through the catheter being used for the normal primary angioplasty treatment using room temperature may be effective in preserving heart muscle, without the shortcomings of entire body cooling. The investigators have already published an initial series of ten cases in which this treatment appeared to be feasible without causing significant clinical problems. The present study is a pilot study designed to assess the rate of patient recruitment and feasibility of this new treatment while exploring some detailed outcomes measuring the restoration of blood flow within the coronary artery at the end of the procedure. Ultimately if the present pilot study is successful, the investigators plan to go on to undertake a much larger randomised outcome study to determine definitively whether this treatment can help reduce heart attack size.

Conditions

Myocardial Infarction; Reperfusion Injury, Myocardial

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Patients recruited per month

  1 year

• Feasibility (Number of studies where all the planned measurements have been collected / total studies)

  Number of studies where all the planned measurements have been collected / total studies

  1 year

• Safety (Adverse events should not be significantly higher in the treatment arm compared to control, nor plausibly caused by the treatment)

  Adverse events should not be significantly higher in the treatment arm compared to control, nor plausibly caused by the treatment as assessed by CTCAE v5.0

  1 year

Secondary Outcomes (60)

• Index of microvascular resistance (IMR) 10 mins after completion of percutaneous coronary intervention and study infusion

  1 hour

• Fractional flow reserve (FFR) 10 mins after completion of percutaneous coronary intervention and study infusion

  1 hour

• Coronary flow reserve (CFR) 10 mins after completion of percutaneous coronary intervention and study infusion

  1 hour

• Resistive reserve ratio (RRR) 10 mins after completion of percutaneous coronary intervention and study infusion

  1 hour

• Resting full-cycle ratio (RFR) 10 mins after completion of percutaneous coronary intervention and study infusion

  1 hour

Study Arms (2)

Transcoronary cooling and dilution

EXPERIMENTAL

Intervention with transcoronary cooling and dilution

Other: Transcoronary cooling and dilution

Standard of care

ACTIVE COMPARATOR

Routine clinical care

Other: Standard of care

Interventions

Transcoronary cooling and dilution OTHER

Transcoronary cooling and dilution

Transcoronary cooling and dilution

Standard of care OTHER

Routine clinical care

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical ST-elevation myocardial infarction or equivalent (e.g. new onset LBBB)
• \<12 Hrs after symptom onset
• Thrombolysis in myocardial infarction (TIMI) 0-1 coronary flow in a target vessel

You may not qualify if:

• History of severe asthma
• Pregnancy
• Severe concomitant disease or conditions with a life expectancy of less than one year.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Harefield Hospital

Uxbridge, UB9 6JH, United Kingdom

RECRUITING

Related Publications (3)

• Otterspoor LC, Van 't Veer M, Van Nunen LX, Brueren GRG, Tonino PAL, Wijnbergen IF, Helmes H, Zimmermann FM, Van Hagen E, Johnson NP, Pijls NHJ. Safety and feasibility of selective intracoronary hypothermia in acute myocardial infarction. EuroIntervention. 2017 Dec 8;13(12):e1475-e1482. doi: 10.4244/EIJ-D-17-00240.

  PMID: 28829744 BACKGROUND

• McGarvey M, Ali O, Iqbal MB, Ilsley C, Wong J, Di Mario C, Redwood S, Patterson T, Pennell DJ, Rogers P, Dalby M; ORCA-3 For the Optimal Restoration of Cardiac Activity (ORCA) Group. A feasibility and safety study of intracoronary hemodilution during primary coronary angioplasty in order to reduce reperfusion injury in myocardial infarction. Catheter Cardiovasc Interv. 2018 Feb 1;91(2):234-241. doi: 10.1002/ccd.27136. Epub 2017 Jun 21.

  PMID: 28636165 BACKGROUND

• Erlinge D, Gotberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Botker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK. Rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. The CHILL-MI trial: a randomized controlled study of the use of central venous catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction. J Am Coll Cardiol. 2014 May 13;63(18):1857-65. doi: 10.1016/j.jacc.2013.12.027. Epub 2014 Feb 5.

  PMID: 24509284 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Reperfusion Injury

Interventions

Indicator Dilution Techniques; Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cardiomyopathies; Reperfusion Injury; Postoperative Complications

Intervention Hierarchy (Ancestors)

Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Miles C Dalby, MD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miles C Dalby, MD

CONTACT

+441895 823737; m.dalby@rbht.nhs.uk

Ira Jakupovic

CONTACT

+44207 3518109; i.jakupovic@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised placebo controlled

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 13, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)