Trial Outcomes & Findings for COOL AMI EU Pivotal Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A) (NCT NCT03173313)
NCT ID: NCT03173313
Last Updated: 2021-02-16
Results Overview
The primary outcome is to compare the mean infarct size in the Test Arm (cooling + PCI) to the mean infarct size in the Control Arm (PCI only) at 4-6 days post infarct.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
111 participants
Primary outcome timeframe
4-6 Days
Results posted on
2021-02-16
Participant Flow
Participant milestones
| Measure |
Cooling + PCI
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 Proteus IVTM System before and after PCI.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
PCI Only
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.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
53
|
|
Overall Study
Informed Consent Signed
|
58
|
53
|
|
Overall Study
Randomized
|
58
|
53
|
|
Overall Study
Cooled
|
54
|
0
|
|
Overall Study
4-6 Day Follow-up
|
57
|
53
|
|
Overall Study
30-day Follow-up
|
52
|
51
|
|
Overall Study
12-month Follow-up
|
49
|
48
|
|
Overall Study
COMPLETED
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
| Measure |
Cooling + PCI
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 Proteus IVTM System before and after PCI.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
PCI Only
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.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Death
|
5
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Diagnosis of Takotsubo Cardiomyopathy
|
0
|
1
|
|
Overall Study
Bone Fracture
|
1
|
0
|
Baseline Characteristics
COOL AMI EU Pivotal Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)
Baseline characteristics by cohort
| Measure |
Cooling + PCI
n=58 Participants
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 Proteus IVTM System before and after PCI.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
PCI Only
n=53 Participants
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.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Bosnia and Herzegovina
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-6 DaysPopulation: Per-protocol population with available infarct size. 19 Test Arm subjects were excluded from the analysis due to not meeting eligibility criteria, having a repeat MI before 4-6 day cMRI, unavailable cMRI, or did not follow cooling per protocol. 9 Control Arm subjects were excluded from the analysis population due to not meeting eligibility criteria, having a repeat MI before 4-6 day cMRI, or unavailable cMRI.
The primary outcome is to compare the mean infarct size in the Test Arm (cooling + PCI) to the mean infarct size in the Control Arm (PCI only) at 4-6 days post infarct.
Outcome measures
| Measure |
Cooling + PCI
n=39 Participants
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 Proteus IVTM System before and after PCI.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
PCI Only
n=44 Participants
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.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
|---|---|---|
|
Relative Reduction of 20% in Mean Anterior Myocardial Infarct Size as Determined by Cardiac Magnetic Resonance (cMR) Imaging at 4-6 Days Post Infarct in the Test Arm (Cooling + PCI) Relative to the Control Arm (PCI Only).
|
21.6 LV%
Standard Deviation 11.5
|
20.9 LV%
Standard Deviation 12.6
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: Per-protocol population. 16 Test Arm subjects were excluded from the analysis due to not meeting eligibility criteria, having a repeat MI before 4-6 day cMRI, or did not follow cooling per protocol. 4 Control Arm subjects were excluded from the analysis population due to not meeting eligibility criteria or having a repeat MI before 4-6 day cMRI.
The primary safety outcome is to compare the per-patient rate of composite Major Adverse Cardiac Events (MACE) in the Test Arm (cooling + PCI) to the Control Arm (PCI only) at 30-Day follow-up to determine non-inferiority to the Control. Composite MACE is defined as Cardiac Death (CD), All Myocardial Re-Infarction (All MI) and Clinically-Indicated Target Vessel Revascularization (CI-TVR).
Outcome measures
| Measure |
Cooling + PCI
n=42 Participants
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 Proteus IVTM System before and after PCI.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
PCI Only
n=49 Participants
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.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
|---|---|---|
|
Per-patient Rate of Composite Major Adverse Cardiac Events (MACE) in Randomized Subjects
Cardiac Death
|
1 Participants
|
0 Participants
|
|
Per-patient Rate of Composite Major Adverse Cardiac Events (MACE) in Randomized Subjects
Cardiac Death and Myocardial re-infarction and clinically-indicated target vessel revascularization
|
1 Participants
|
0 Participants
|
|
Per-patient Rate of Composite Major Adverse Cardiac Events (MACE) in Randomized Subjects
No MACE Event
|
40 Participants
|
49 Participants
|
Adverse Events
Cooling + PCI
Serious events: 18 serious events
Other events: 45 other events
Deaths: 5 deaths
PCI Only
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cooling + PCI
n=58 participants at risk
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 Proteus IVTM System before and after PCI.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
PCI Only
n=53 participants at risk
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.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
3.4%
2/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Vascular disorders
Cardiogenic shock
|
10.3%
6/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Infections and infestations
Infections - listed
|
8.6%
5/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myocardial infarction
|
1.7%
1/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Cardiac disorders
Other cardiac - listed
|
8.6%
5/58 • 30 Days
Adverse Events
|
1.9%
1/53 • 30 Days
Adverse Events
|
|
Cardiac disorders
Pulmonary edema
|
1.7%
1/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Metabolism and nutrition disorders
Respiratory failure
|
3.4%
2/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Vascular disorders
Stent thrombosis
|
3.4%
2/58 • 30 Days
Adverse Events
|
1.9%
1/53 • 30 Days
Adverse Events
|
|
Cardiac disorders
Ventricular fibrillation
|
10.3%
6/58 • 30 Days
Adverse Events
|
3.8%
2/53 • 30 Days
Adverse Events
|
|
Cardiac disorders
Ventricular tachycardia
|
3.4%
2/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Renal and urinary disorders
Acute renal insufficiency
|
1.7%
1/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Vascular disorders
Bleeding
|
3.4%
2/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Vascular disorders
Hematoma
|
1.7%
1/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Metabolism and nutrition disorders
Hypernatraemia/Hyponatraemia
|
1.7%
1/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Nervous system disorders
Loss of consciousness
|
1.7%
1/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Vascular disorders
Vascular perforation or dissection
|
1.7%
1/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
Other adverse events
| Measure |
Cooling + PCI
n=58 participants at risk
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 Proteus IVTM System before and after PCI.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
PCI Only
n=53 participants at risk
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.
Intravascular permissive hypothermia as an adjunct to PCI: Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
43.1%
25/58 • 30 Days
Adverse Events
|
3.8%
2/53 • 30 Days
Adverse Events
|
|
Infections and infestations
Infections - listed
|
12.1%
7/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Cardiac disorders
Other cardiac - listed
|
27.6%
16/58 • 30 Days
Adverse Events
|
20.8%
11/53 • 30 Days
Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Uncontrolled shivering
|
20.7%
12/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
|
Cardiac disorders
Ventricular tachycardia
|
5.2%
3/58 • 30 Days
Adverse Events
|
1.9%
1/53 • 30 Days
Adverse Events
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/58 • 30 Days
Adverse Events
|
7.5%
4/53 • 30 Days
Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
3/58 • 30 Days
Adverse Events
|
1.9%
1/53 • 30 Days
Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
12.1%
7/58 • 30 Days
Adverse Events
|
5.7%
3/53 • 30 Days
Adverse Events
|
|
Psychiatric disorders
Sleep disorder
|
5.2%
3/58 • 30 Days
Adverse Events
|
3.8%
2/53 • 30 Days
Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
3/58 • 30 Days
Adverse Events
|
0.00%
0/53 • 30 Days
Adverse Events
|
Additional Information
Vice President of Clinical Affairs
ZOLL Circulation, Inc.
Phone: (408) 541-2140
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place