STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A) (STEMI Cool)
Primary Purpose
Acute Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cooling Procedure using the ZOLL Thermogard XP3 IVTM System
PCI
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring STEMI
Eligibility Criteria
Inclusion Criteria:
- The patient is >= 18 years of age.
- The patient must have symptoms consistent with AMI (i.e. chest pain, arm pain, etc.) and unresponsive to nitroglycerin, with symptoms beginning greater than 60 minutes but less than 4.5 hours prior to presentation at Hospital.
- Evidence of Acute Anterior MI with ST-segment elevation of >= 0.2 mV in two or more anterior contiguous precordial leads (V1-V4), as confirmed by ECG at baseline.
- The patient is eligible for primary PCI.
- The patient's condition and site workflow allow for the feasibility of implementing the cooling protocol within trial protocol specific requirements.
- The patient or patient's legal representative is willing to provide written, informed consent to participate in this clinical trial.
Exclusion Criteria:
- The patient has had a previous myocardial infarction.
- The patient is experiencing cardiogenic shock, systolic blood pressure [SBP] <100 mmHg, HR>100 bpm and arterial oxygen saturation (pulse oximetry) <= 92% without additional oxygen.
- The patient has known history of Congestive Heart Failure (CHF), hepatic failure, end stage kidney disease or severe renal failure (clearance < 30ml/min/1.73m²).
- The patient is presenting with resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class III through IV.
- The patient has an aortic dissection or requires an immediate surgical or procedural intervention other than PCI.
- The patient is febrile (temperature > 37.5 °C) or has experienced any infection in the last 5 days.
- The patient has a known previous CABG.
- The patient has a known recent stroke within 90 days of admission.
- Cardio-pulmonary 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 (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans).
- Any contraindication to cardiac Magnetic Resonance Imaging (MRI), or any implant in the upper body which may cause artifacts on cardiac MRI imaging.
- The patient has a known hypersensitivity or contraindication to aspirin, heparin, or anaphylaxis to contrast media, 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 transfusions.
- The patient has a height of <1.5 meters (4 feet 11 inches).
- The patient has a known hypersensitivity or contraindication to Buspirone hydrochloride or Meperidine and/or has been treated with a monoamine oxidase inhibitor in the past 14 days.
- Patient has a known history of untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the physician would be incompatible with Meperidine administration.
- The patient has an Inferior Vena Cava filter in place (IVC).
- The patient has an anticipated life expectancy of <1 year.
- The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
- The patient is currently enrolled in another investigational drug or device 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 a Gadolinium allergy.
- The patient has received thrombolytic therapy en route to the hospital.
- The patient has received any oral P2Y12 inhibitors prior to enrollment.
- The patient shows clinical evidence of spontaneous reperfusion as observed symptomatically and/or from ECG findings (partial or complete ST resolution in ECG prior to informed consent and randomization).
- 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 or expected to become pregnant.
- In the opinion of Investigator or designee the patient is not willing and able to comply with all the study requirements.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cooling + PCI
PCI only
Arm Description
The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Thermogard XP3 IVTM System before and after PCI.
The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only.
Outcomes
Primary Outcome Measures
Phase A Safety Endpoint: Incidence of MACE at 30 days.
MACE is defined as Subjects who experienced any of the following events:
All-cause death (cardiac, vascular, non-cardiovascular)
Myocardial infarction (MI)
Clinically-indicated target vessel revascularization (CI TVR)
Definite or probable stent thrombosis (ST)
New or worsening heart failure (HF) after 24 hours from the end of index PCI, or subsequent re-hospitalization for HF
Stroke
Major bleeding
Phase A Device Performance Endpoint: Proportion of cooled patients who reach ≤34° at PCI.
Secondary Outcome Measures
Phase A Secondary Safety Endpoint 1: Proportion of patients reaching <90 min door-to-balloon time.
The performance goal is at least 93.5% of the patients in Phase A, with Test and Control arms evaluated separately.
Phase A Secondary Safety Endpoint 2: Rate of a composite safety endpoint at 30 days.
Rate of a composite safety endpoint at 30 days defined as the following:
Cardiovascular death
Myocardial infarction (MI)
Clinically-indicated target vessel revascularization (CI TVR)
Definite or probable stent thrombosis (ST)
New or worsening heart failure (HF) after 24 hours from the end of index PCI, or subsequent re-hospitalization for HF
Stroke
Major bleeding
Full Information
NCT ID
NCT03361995
First Posted
November 8, 2017
Last Updated
October 21, 2020
Sponsor
ZOLL Circulation, Inc., USA
1. Study Identification
Unique Protocol Identification Number
NCT03361995
Brief Title
STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)
Acronym
STEMI Cool
Official Title
STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients With Acute Myocardial Infarction (Phase A)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZOLL Circulation, Inc., USA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Multicenter, Prospective, Randomized-Controlled Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients with Acute Myocardial Infarction. The Phase A portion of the trial will include 80 enrollments from up to 15 sites.
Detailed Description
The overall objective of this randomized trial is to evaluate the Safety and Efficacy of intravascular cooling using the ZOLL Thermogard XP3 IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction and undergoing PCI.
The objective of the Phase A trial is to demonstrate successful incorporation of intravascular cooling into US standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
STEMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cooling + PCI
Arm Type
Experimental
Arm Description
The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Thermogard XP3 IVTM System before and after PCI.
Arm Title
PCI only
Arm Type
Active Comparator
Arm Description
The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow PCI only.
Intervention Type
Device
Intervention Name(s)
Cooling Procedure using the ZOLL Thermogard XP3 IVTM System
Intervention Description
Cooling Procedure with ZOLL Thermogard XP3 IVTM System before and after Percutaneous Coronary Intervention (PCI)
Intervention Type
Device
Intervention Name(s)
PCI
Intervention Description
Standard of Care for PCI
Primary Outcome Measure Information:
Title
Phase A Safety Endpoint: Incidence of MACE at 30 days.
Description
MACE is defined as Subjects who experienced any of the following events:
All-cause death (cardiac, vascular, non-cardiovascular)
Myocardial infarction (MI)
Clinically-indicated target vessel revascularization (CI TVR)
Definite or probable stent thrombosis (ST)
New or worsening heart failure (HF) after 24 hours from the end of index PCI, or subsequent re-hospitalization for HF
Stroke
Major bleeding
Time Frame
Through study completion, approximately 1 year
Title
Phase A Device Performance Endpoint: Proportion of cooled patients who reach ≤34° at PCI.
Time Frame
Through study completion, approximately 1 year
Secondary Outcome Measure Information:
Title
Phase A Secondary Safety Endpoint 1: Proportion of patients reaching <90 min door-to-balloon time.
Description
The performance goal is at least 93.5% of the patients in Phase A, with Test and Control arms evaluated separately.
Time Frame
Through study completion, approximately 1 year
Title
Phase A Secondary Safety Endpoint 2: Rate of a composite safety endpoint at 30 days.
Description
Rate of a composite safety endpoint at 30 days defined as the following:
Cardiovascular death
Myocardial infarction (MI)
Clinically-indicated target vessel revascularization (CI TVR)
Definite or probable stent thrombosis (ST)
New or worsening heart failure (HF) after 24 hours from the end of index PCI, or subsequent re-hospitalization for HF
Stroke
Major bleeding
Time Frame
Through study completion, approximately 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient is >= 18 years of age.
The patient must have symptoms consistent with AMI (i.e. chest pain, arm pain, etc.) and unresponsive to nitroglycerin, with symptoms beginning greater than 60 minutes but less than 4.5 hours prior to presentation at Hospital.
Evidence of Acute Anterior MI with ST-segment elevation of >= 0.2 mV in two or more anterior contiguous precordial leads (V1-V4), as confirmed by ECG at baseline.
The patient is eligible for primary PCI.
The patient's condition and site workflow allow for the feasibility of implementing the cooling protocol within trial protocol specific requirements.
The patient or patient's legal representative is willing to provide written, informed consent to participate in this clinical trial.
Exclusion Criteria:
The patient has had a previous myocardial infarction.
The patient is experiencing cardiogenic shock, systolic blood pressure [SBP] <100 mmHg, HR>100 bpm and arterial oxygen saturation (pulse oximetry) <= 92% without additional oxygen.
The patient has known history of Congestive Heart Failure (CHF), hepatic failure, end stage kidney disease or severe renal failure (clearance < 30ml/min/1.73m²).
The patient is presenting with resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class III through IV.
The patient has an aortic dissection or requires an immediate surgical or procedural intervention other than PCI.
The patient is febrile (temperature > 37.5 °C) or has experienced any infection in the last 5 days.
The patient has a known previous CABG.
The patient has a known recent stroke within 90 days of admission.
Cardio-pulmonary 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 (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans).
Any contraindication to cardiac Magnetic Resonance Imaging (MRI), or any implant in the upper body which may cause artifacts on cardiac MRI imaging.
The patient has a known hypersensitivity or contraindication to aspirin, heparin, or anaphylaxis to contrast media, 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 transfusions.
The patient has a height of <1.5 meters (4 feet 11 inches).
The patient has a known hypersensitivity or contraindication to Buspirone hydrochloride or Meperidine and/or has been treated with a monoamine oxidase inhibitor in the past 14 days.
Patient has a known history of untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the physician would be incompatible with Meperidine administration.
The patient has an Inferior Vena Cava filter in place (IVC).
The patient has an anticipated life expectancy of <1 year.
The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
The patient is currently enrolled in another investigational drug or device 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 a Gadolinium allergy.
The patient has received thrombolytic therapy en route to the hospital.
The patient has received any oral P2Y12 inhibitors prior to enrollment.
The patient shows clinical evidence of spontaneous reperfusion as observed symptomatically and/or from ECG findings (partial or complete ST resolution in ECG prior to informed consent and randomization).
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 or expected to become pregnant.
In the opinion of Investigator or designee the patient is not willing and able to comply with all the study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Creech, PhD
Phone
3233096949
Email
jcreech@zoll.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esha Kothari, MSc
Phone
6506868086
Email
ekothari@zoll.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The study is registered on ClinicalTrials.gov to make information about the trial publicly available. At all times, including early termination of the study, the sponsors will comply with the reporting requirements of applicable clinical trials registered on ClinicalTrials.gov under the FDA Amendments Act (FDAAA).
Learn more about this trial
STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)
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