NCT02664194

Brief Summary

To evaluate and improve the safety and efficacy of hypothermia as an adjunctive therapy to percutaneous coronary intervention in patients with acute myocardial infarction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

January 18, 2016

Last Update Submit

May 4, 2018

Conditions

Hypothermia, InducedRewarmingMyocardial InfarctionPercutaneous Cornonary Intervention

Keywords

HypothermiaRewarmingMyocardial InfarctionPercutaneous Cornonary Intervention

Outcome Measures

Primary Outcomes (3)

  • Infarct size

    Reduction of the infarct size (%LV), studied with cardiac magnetic resonance imaging(cMR) using late gadolinium enhancement 5 days after the AMI, and 30 days after the infarction.

    30 days after STEMI

  • Ejection fraction

    ejection fraction (%) as determined cardiac resonance imaging (cMR) at 30 days after randomization.

    30 days after STEMI

  • MACE

    Incidence up to 30 days after randomization of major adverse cardiac events (MACE), defined as: death related to cardiac complications, recurrent AMI or need for revascularization of the target vessel.

    30 days after STEMI

Secondary Outcomes (8)

  • ST Segment Elevation

    3 hours after STEMI

  • Cardiac enzymes

    30 days after STEMI

  • Composite of adverse events

    30 days after STEMI

  • Device complications

    30 days after STEMI

  • Cooling complications

    30 days after STEMI

  • +3 more secondary outcomes

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Primary percutaneous coronary intervention only

Procedure: Primary Percutaneous Coronary Intervention

03 Hours Hypothermia Group - Proteus® Cooling System

EXPERIMENTAL

03 hours of intravascular hypothermia as an adjunctive method to primary percutaneous coronary intervention, adjunct hypothermia methods and parameters using Proteus® Cooling System.

Device: Proteus® Cooling SystemProcedure: Primary Percutaneous Coronary Intervention

01 Hour Hypothermia Group - Proteus® Cooling System

EXPERIMENTAL

01 hour of intravascular hypothermia as an adjunctive method to primary percutaneous coronary intervention, adjunct hypothermia methods and parameters using Proteus® Cooling System.

Device: Proteus® Cooling SystemProcedure: Primary Percutaneous Coronary Intervention

Interventions

Proteus® Cooling SystemDEVICE

Intravascular hypothermia as an adjunctive method to primary percutaneous coronary intervention, adjunct hypothermia methods and parameters, using Proteus® Cooling System.

Also known as: Cooling / Hypothermia
01 Hour Hypothermia Group - Proteus® Cooling System03 Hours Hypothermia Group - Proteus® Cooling System
Primary Percutaneous Coronary InterventionPROCEDURE

Primary percutaneous coronary intervention

Also known as: Primary Angioplasty
01 Hour Hypothermia Group - Proteus® Cooling System03 Hours Hypothermia Group - Proteus® Cooling SystemControl Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient aged \> 18 years.
  • The patient must have symptoms consistent with an acute myocardial infarction (chest pain, that is, pain in the arm, etc.) that do not improve with nitroglycerin, with an onset of symptoms greater than 30 minutes but less than six hours before admission to the emergency room.
  • Roll-In Patients: Anterior or Inferior MI with ST-segment elevation of \> 1mm in two or more contiguous anterior precordial or inferior leads.
  • Randomized Patients: Anterior wall AMI with elevation of ST segment \> 1mm in two or more anterior precordial contiguous leads.
  • Patient must be eligible for PCI.
  • The patient or the patient's legal guardian agrees to and is willing to sign the informed consent form to participate in the clinical study (for countries where appropriate).

You may not qualify if:

  • The patient had a previous myocardial infarction.
  • The patient is experiencing cardiogenic shock (systolic blood pressure (SBP) \< 80 mmHg and not responsive to fluids, or SBP \< 100 mmHg with vasopressors, or in need of an intra-aortic balloon - IAB).
  • The patient is presenting with resuscitated cardiac arrest, atrial fibrillation or Killip risk Stratification class II through IV.
  • The patient has aortic dissection or requires an immediate surgical or procedural intervention other than PCI.
  • The patient has known Congestive Heart Failure (CHF), hepatic failure, end-stage kidney disease or sever renal failure (clearance \< 30 ml/min/1.73m2 .
  • The patient is febrile (temperature \> 37.5 °) or has experienced an infection with fever in the last 5 days.
  • The patient has known previous CABG.
  • The patient has known recent stroke within 90 days of admission.
  • Cardiopulmonsary decompensation that has occurred en route to the hospital or in the opinion of the physician that is imminent or likely to occur following presentation to the clinical site.
  • Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis 9e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans.
  • The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast \[agents\], which cannot be adequately pre-medicated.
  • The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia or sickle cell anemia, or will refuse blood transfusion.
  • The patient is \< 1.5 m (4 feet 11 inches) tall.
  • The patient has a known hypersensitivity to buspirone hydrochloride or meperidine and/or was treated with a monoamine oxidase inhibitor in the last 14 days.
  • The patient has a known history of severe hepatic or renal failure, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy or urethral stricture, that in the opinion of the physician, would be incompatible with the administration of pethidine/meperidine.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InCor - Instituto do Coracao - HCFMUSP

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (4)

  • Dae MW, Gao DW, Ursell PC, Stillson CA, Sessler DI. Safety and efficacy of endovascular cooling and rewarming for induction and reversal of hypothermia in human-sized pigs. Stroke. 2003 Mar;34(3):734-8. doi: 10.1161/01.STR.0000057461.56040.FE. Epub 2003 Feb 13.

    PMID: 12624300BACKGROUND

  • Gotberg M, Olivecrona GK, Koul S, Carlsson M, Engblom H, Ugander M, van der Pals J, Algotsson L, Arheden H, Erlinge D. A pilot study of rapid cooling by cold saline and endovascular cooling before reperfusion in patients with ST-elevation myocardial infarction. Circ Cardiovasc Interv. 2010 Oct;3(5):400-7. doi: 10.1161/CIRCINTERVENTIONS.110.957902. Epub 2010 Aug 24.

    PMID: 20736446RESULT

  • Dallan LAP, Dae M, Giannetti NS, Polastri TF, Lima MKF, Rochitte CE, Hajjar LA, San Martin CYB, Lima FG, Nicolau JC, de Oliveira MT Jr, Dallan LAO, Ribeiro da Silva EE, Kalil Filho R, Abizaid A, Lemos Neto PA, Timerman S. Endovascular therapeutic hypothermia adjunctive to percutaneous coronary intervention in acute myocardial infarction: realistic simulation as a game changer. Rev Cardiovasc Med. 2022 Mar 16;23(3):104. doi: 10.31083/j.rcm2303104.

    PMID: 35345271DERIVED

  • Dallan LAP, Giannetti NS, Rochitte CE, Polastri TF, San Martin CYB, Hajjar LA, Lima FG, Nicolau JC, Oliveira MT , Jr, Dae M, Ribeiro da Silva EE, Kalil Filho R, Lemos Neto PA, Timerman S. Cooling as an Adjunctive Therapy to Percutaneous Intervention in Acute Myocardial Infarction: COOL-MI InCor Trial. Ther Hypothermia Temp Manag. 2021 Sep;11(3):135-144. doi: 10.1089/ther.2020.0018. Epub 2020 Jun 17.

    PMID: 32552523DERIVED

MeSH Terms

Conditions

HypothermiaMyocardial Infarction

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Sergio Timerman, PhD

    InCor - FMUSP

    PRINCIPAL INVESTIGATOR

  • Pedro A Lemos, PhD

    InCor - FMUSP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Augusto Dallan, MD

CONTACT

5511 2661-5000guto.dallan@incor.usp.br

Sergio Timerman, PhD

CONTACT

5511 2661-5000sergio.timerman@incor.usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 26, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

BR(1)