- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04562272
Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP (UNLOAD-AMI)
September 20, 2020 updated by: Marek Sramko, Institute for Clinical and Experimental Medicine
Attenuation of Post-infarct Remodeling in Patients With Acute Myocardial Infarction by Left Ventricular Mechanical Unloading Using Impella-CP
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Prague, Czechia, 14059
- Recruiting
- Institute for Clinical and Experimental Medicine (IKEM)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mechanical unloading
Mechanical unloading by Impella-CP for 36-48 hours, on top of the standard treatment
|
The patients will receive Impella-CP for 36-48 hours.
The pump speed and LV unloading will be guided by PCWP (Swan-Ganz catheter)
Other Names:
|
No Intervention: Standard care
Standard treatment of AMI after PCI according to guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the left ventricular end-systolic volume
Time Frame: LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months
|
Absolute change in the LVESV measured by SPECT and compared between the groups
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LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months
|
Occurrence of LV remodeling
Time Frame: LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months
|
Occurrence of LV remodeling defined by the increase of LV end-systolic volume >20%
|
LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months
|
Extent of post-infarct scar
Time Frame: LV scar extent measured during the index hospitalization (day 5-7) and at 3 months
|
Extent of post-infarct scar measured by Tc-SPECT and compared between the groups
|
LV scar extent measured during the index hospitalization (day 5-7) and at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CV complications
Time Frame: during the first 5 day after AMI
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occurence of TIMI bleeding, hemolysis, thromboembolic events
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during the first 5 day after AMI
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heart failure
Time Frame: during the first 5 day after AMI
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acute heart failure requiring inotropes or progression of cardiogenic shock
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during the first 5 day after AMI
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self-assessed dyspnea
Time Frame: day 1, 2 and 5
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dyspnea reported by the patient on a Likert scale
|
day 1, 2 and 5
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lung water
Time Frame: day 1, 2 and 5
|
assessment of lung water score by ultrasound
|
day 1, 2 and 5
|
maximum hs-TnT, BNP, serum lactate
Time Frame: during the first 5 day after AMI
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diference in hs-TnT, BNP and lactate between the groups
|
during the first 5 day after AMI
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2020
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
September 20, 2020
First Submitted That Met QC Criteria
September 20, 2020
First Posted (Actual)
September 24, 2020
Study Record Updates
Last Update Posted (Actual)
September 24, 2020
Last Update Submitted That Met QC Criteria
September 20, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15849/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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