Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP (UNLOAD-AMI)
Primary Purpose
Myocardial Infarction, Remodeling, Ventricular, Shock, Cardiogenic
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
LV mechanical unloading by Impella-CP
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring ventricular assist device, Impella, unloading
Eligibility Criteria
Inclusion Criteria:
- large anterior wall AMI with estimated ischemia of <24h
- at risk of the beginning of cardiogenic shock (SCAI A/B)
- blood pressure <160/100 mmHg
- no previous IM based on the patient's history
- no previously known LV systolic dysfunction
- assumed new LV dysfunction documented by ECHO or LVG (LVEF < 45%)
- infarct culprit lesion at the proximal LAD, LMCA or equivalent, with TIMI <= 2 flow
- LV end-diastolic pressure of >= 18 mmHg measured invasively
Exclusion Criteria:
- history of chronic LV dysfunction
- chronic anticoagulation therapy
- the need of IIb/IIIa blockers at the PCI
- inadequate femoral vein access (peripheral artery disease)
- significant valve disease or valve prosthesis
- CPR >5 min before PCI
- LV thrombus
- periprocedural AMI (obliteration of large non-culprit artery during PCI)
Sites / Locations
- Institute for Clinical and Experimental Medicine (IKEM)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Mechanical unloading
Standard care
Arm Description
Mechanical unloading by Impella-CP for 36-48 hours, on top of the standard treatment
Standard treatment of AMI after PCI according to guidelines.
Outcomes
Primary Outcome Measures
Difference in the left ventricular end-systolic volume
Absolute change in the LVESV measured by SPECT and compared between the groups
Occurrence of LV remodeling
Occurrence of LV remodeling defined by the increase of LV end-systolic volume >20%
Extent of post-infarct scar
Extent of post-infarct scar measured by Tc-SPECT and compared between the groups
Secondary Outcome Measures
CV complications
occurence of TIMI bleeding, hemolysis, thromboembolic events
heart failure
acute heart failure requiring inotropes or progression of cardiogenic shock
Full Information
NCT ID
NCT04562272
First Posted
September 20, 2020
Last Updated
September 20, 2020
Sponsor
Institute for Clinical and Experimental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04562272
Brief Title
Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
Acronym
UNLOAD-AMI
Official Title
Attenuation of Post-infarct Remodeling in Patients With Acute Myocardial Infarction by Left Ventricular Mechanical Unloading Using Impella-CP
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Clinical and Experimental Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with anterior wall AMI treated by PCI will undergo, after successful revascularization of the infarct artery, measurement of the left ventricular pressure, and femoral angiogram. Patients with elevated LV pressure and adequate femoral access will be randomized to standard pharmacological treatment of AMI vs. mechanical unloading by Impella-CP (on top of the standard treatment) for 36-48 hours. LV unloading will be guided by measurement of PCWP by Swan-Ganz catheter. On the day 4-7, and at 3 months after the AMI, the patients will undergo SPECT and 3D-echocardiography to assess ventricular remodeling and extent of the post-infarct scar. The patients will be followed for at least 12 months for the occurrence of heart failure and adverse cardiovascular events. The study will test the hypothesis, whether the LV mechanical unloading after PCI will attenuate post-infarct scar and cardiac remodeling.
Detailed Description
Eligible patients with be screened before PCI
The patients with undergo coronary angiography and PCI according to common medical practice
At the end of the PCI procedure, after a successful revascularization, a pigtail catheter will be used to measure LV filling pressure and to perform femoral angiography (to evaluate femoral access).
Patients fulfilling angiographic and hemodynamic criteria will be randomized 1:1 to standard care vs. mechanical unloading by Impella-CP.
The patients will be treated on a CCU with experience with use of Impella-CP.
On the CCU, all patients will be monitored by a Swan-Ganz catheter for 48 hours.
The pump speed will be adjusted to maintain the lowest tolerated PCWP while avoiding suction events.
Mechanical unloading will last 36-48h. Afterwards, the Impella-CP will be explanted.
All patients will receive standard pharmacotherapy of AMI, according to the guidelines.
Revascularization of significant non-infarct lesions will be performed during the index hospitalization.
3D-echocardiography and Tc-SPECT (D-SPECT) will be performed on the day 5-7 of the index hospitalization. LV phasic volumes and extent of nonperfused myocardium (scar) will be evaluated automatically, using software provided by the vendor.
3D-echocardiography and Tc-SPECT will be repeated at 3 months after the AMI.
The patients will be followed by out-patient check-ups every 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Remodeling, Ventricular, Shock, Cardiogenic
Keywords
ventricular assist device, Impella, unloading
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mechanical unloading
Arm Type
Active Comparator
Arm Description
Mechanical unloading by Impella-CP for 36-48 hours, on top of the standard treatment
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard treatment of AMI after PCI according to guidelines.
Intervention Type
Procedure
Intervention Name(s)
LV mechanical unloading by Impella-CP
Other Intervention Name(s)
Abiomed Impella-CP
Intervention Description
The patients will receive Impella-CP for 36-48 hours. The pump speed and LV unloading will be guided by PCWP (Swan-Ganz catheter)
Primary Outcome Measure Information:
Title
Difference in the left ventricular end-systolic volume
Description
Absolute change in the LVESV measured by SPECT and compared between the groups
Time Frame
LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months
Title
Occurrence of LV remodeling
Description
Occurrence of LV remodeling defined by the increase of LV end-systolic volume >20%
Time Frame
LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months
Title
Extent of post-infarct scar
Description
Extent of post-infarct scar measured by Tc-SPECT and compared between the groups
Time Frame
LV scar extent measured during the index hospitalization (day 5-7) and at 3 months
Secondary Outcome Measure Information:
Title
CV complications
Description
occurence of TIMI bleeding, hemolysis, thromboembolic events
Time Frame
during the first 5 day after AMI
Title
heart failure
Description
acute heart failure requiring inotropes or progression of cardiogenic shock
Time Frame
during the first 5 day after AMI
Other Pre-specified Outcome Measures:
Title
self-assessed dyspnea
Description
dyspnea reported by the patient on a Likert scale
Time Frame
day 1, 2 and 5
Title
lung water
Description
assessment of lung water score by ultrasound
Time Frame
day 1, 2 and 5
Title
maximum hs-TnT, BNP, serum lactate
Description
diference in hs-TnT, BNP and lactate between the groups
Time Frame
during the first 5 day after AMI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
large anterior wall AMI with estimated ischemia of <24h
at risk of the beginning of cardiogenic shock (SCAI A/B)
blood pressure <160/100 mmHg
no previous IM based on the patient's history
no previously known LV systolic dysfunction
assumed new LV dysfunction documented by ECHO or LVG (LVEF < 45%)
infarct culprit lesion at the proximal LAD, LMCA or equivalent, with TIMI <= 2 flow
LV end-diastolic pressure of >= 18 mmHg measured invasively
Exclusion Criteria:
history of chronic LV dysfunction
chronic anticoagulation therapy
the need of IIb/IIIa blockers at the PCI
inadequate femoral vein access (peripheral artery disease)
significant valve disease or valve prosthesis
CPR >5 min before PCI
LV thrombus
periprocedural AMI (obliteration of large non-culprit artery during PCI)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marek Sramko, MD, PhD
Phone
+420731682681
Email
marek.sramko@ikem.cz
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine (IKEM)
City
Prague
ZIP/Postal Code
14059
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Sramko, MD, PhD
Phone
+420731682681
Email
marek.sramko@ikem.cz
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
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