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Hypothermia, InducedCOOL-MI InCorNCT02664194

Hypothermia as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction

A study testing Proteus® Cooling System and Primary Percutaneous Coronary Intervention in people with Hypothermia, Induced and Rewarming, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Proteus® Cooling System and Primary Percutaneous Coronary Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteBrazil
Study dates
Jan 2016to Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.
  • The patient has an Inferior Vena Cava filter in place (IVC).
  • The patient has a pre-MI life expectancy < 1 year due to underlying medical conditions or pre-existing morbidities.
  • The patient has a known, unresolved history of drug use or alcohol dependency, or is not able to comprehend or follow the instructions.
  • The patient is currently enrolled in another investigational drug or device trial that has not completed the primary endpoint. (Note: For the purpose of this protocol, patients involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial).
  • The patient is apprehensive about or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy, or is in permanent Atrial Fibrillation.
  • The patient has received thrombolytic therapy en route to the hospital
  • The patient shows clinical evidence of spontaneous reperfusion as observed symptomatically and/ or from ECG findings (partial or complete ST resolution in ECG before randomization) upon admission
  • The patient is a vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state)
  • The patient is a female who is known to be pregnant.

Trial locations and contacts

1 site in 1 country.

Luis Augusto Dallan, MD contact

5511 2661-5000 ext. 5014

guto.dallan@incor.usp.br

Sergio Timerman, PhD contact

5511 2661-5000 ext. 5596

sergio.timerman@incor.usp.br

Brazil1 site, 1 recruiting

  • InCor - Instituto do Coracao - HCFMUSP

    São Paulo, São Paulo, 05403000

    Luis Augusto Dallan, MD, 5511 2661-5000 ext. 5014, guto.dallan@incor.usp.br

    Sergio Timerman, PhD, 5511 2661-5000 ext. 5596, sergio.timerman@incor.usp.br

    Recruiting

Other trials in Brazil

About this study

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

Read the detailed description

Single-center, prospective, randomized, controlled clinical study involving at least 70 patients with up to 10 roll-in patients (for training purposes).

Male and female adults presenting with acute myocardial infarction may be eligible for this research study. To qualify, patients must go to the Emergency Room within up to 6 hours of onset of chest pain, present with anterior or inferior acute myocardial infarction with elevation of the ST segment greater than 1mm in 2 or more contiguous leads in the anterior or inferior wall and be eligible for the performance of a percutaneous intervention procedure.

The intervention will be intravascular hypothermia using Proteus System® as an adjunctive method to percutaneous coronary intervention, adjunct hypothermia methods and parameters.

During the randomization phase, at least 70 patients who meet the eligibility criteria will be randomly assigned to the 03 hour hypothermia group (percutaneous coronary intervention + cooling), to the 01 hour hypothermia group (percutaneous coronary intervention + cooling) or to the control group (percutaneous coronary intervention only) in a 1:1:1 ratio.

All patients receiving PCI + Cooling will also be randomized to groups A and B. Group A will receive 1 liter of chilled normal saline (4°C) prior to PCI/reperfusion, and Group B will not receive chilled normal saline (4°C), prior to PCI.

All patients included in the randomization phase will be included in the statistical analysis.

Approximately 10 Roll-in patients may be enrolled at the center (for training purpose), with anterior or inferior wall infarcts.

The primary endpoint will be 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.

The secundary endpoints will be

  • incidence of major adverse cardiac events (MACE) or death within 30 days;
  • resolution of the ST segment elevation after PCI;
  • ejection fraction determined by cMR after 30 days.
  • evaluation of adverse events potentially related to hypothermia and/or endovascular cooling within 30 days.
  • Differences in plaquelet aggregation during cooling and rewarming.
Being tested
Proteus® Cooling System, Primary Percutaneous Coronary Intervention
Keywords
Hypothermia, Rewarming, Myocardial Infarction, Percutaneous Cornonary Intervention
Medical subject headings
Hypothermia, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proteus® Cooling SystemDevice

    Also called Cooling / Hypothermia

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

  • Primary Percutaneous Coronary InterventionProcedure or surgery

    Also called Primary Angioplasty

    Primary percutaneous coronary intervention

Study groups in NCT02664194
Study groupRoleWhat they receive
Control GroupActive comparatorPrimary percutaneous coronary intervention only
Receives: Procedure: Primary Percutaneous Coronary Intervention
03 Hours Hypothermia Group - Proteus® Cooling SystemExperimental03 hours of intravascular hypothermia as an adjunctive method to primary percutaneous coronary intervention, adjunct hypothermia methods and parameters using Proteus® Cooling System.
Receives: Device: Proteus® Cooling System; Procedure: Primary Percutaneous Coronary Intervention
01 Hour Hypothermia Group - Proteus® Cooling SystemExperimental01 hour of intravascular hypothermia as an adjunctive method to primary percutaneous coronary intervention, adjunct hypothermia methods and parameters using Proteus® Cooling System.
Receives: Device: Proteus® Cooling System; Procedure: Primary Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days after STEMI

  2. Ejection fraction

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

    Measured: 30 days after STEMI

  3. 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.

    Measured: 30 days after STEMI

Secondary outcomes (8)

  1. ST Segment Elevation

    Resolution of the ST segment elevation (milimiters) after PCI.

    Measured: 3 hours after STEMI

  2. Cardiac enzymes

    Serial evaluation of cardiac enzymes (Troponin I - ng/mL) in order to provide a secondary measure of cell injury

    Measured: 30 days after STEMI

  3. Composite of adverse events

    Composite of adverse events, defined as:

    1. All-cause mortality
    2. Recurrent AMI
    3. Need for revascularization of the target vessel
    4. Cerebral vascular accident
    5. Cardiogenic shock
    6. Pulmonary embolism
    7. Ventricular fibrillation
    8. Vascular complications requiring surgery
    9. Bleeding requiring transfusion of 2 or more units of red blood cell concentrate

    Measured: 30 days after STEMI

  4. Device complications

    Complications potentially related to the implantation or to the use of the ZOLL System (hematoma, venous puncture, vascular complications requiring surgery, bleeding, surgical wound infection, systemic infection, deep venous thrombosis, pulmonary embolism by tomography)

    Measured: 30 days after STEMI

  5. Cooling complications

    Potential complications related to cooling (thermal discomfort, myocardial ischemia, coagulopathy, arrhythmias, hypotension and pulmonary edema).

    Measured: 30 days after STEMI

  6. All cause mortality

    All cause mortality

    Measured: 30 days after STEMI

  7. Anterior MI

    Patients with elevation of the ST segment greater than 1mm in 2 or more contiguous leads in the anterior wall (v1 to v6)

    Measured: 30 days after STEMI

  8. 03 hours versus 01 hour cooling

    Comparison of three hours of cooling versus one hour of cooling regarding infarct size (%LV) as determined by study with cardiac magnetic resonance

    Measured: 30 days after STEMI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2019 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02664194
Sponsor's protocol ID
16568
Other IDs
0242/11, 3575/10/164
Acronym
COOL-MI InCor
Status last verified
May 2018
First submitted
18 Jan 2016
Last updated
11 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 12624300

  • 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.

    PubMed 20736446

  • 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.

    PubMed 35345271

  • 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.

    PubMed 32552523

Questions about this trial

What is this clinical trial studying?

A study testing Proteus® Cooling System and Primary Percutaneous Coronary Intervention in people with Hypothermia, Induced and Rewarming, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luis Augusto Dallan, MD (5511 2661-5000 ext. 5014, guto.dallan@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infarct size (time frame: 30 days after STEMI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02664194, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.

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