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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Eligible patients with be screened before PCI
  2. The patients with undergo coronary angiography and PCI according to common medical practice
  3. 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).
  4. Patients fulfilling angiographic and hemodynamic criteria will be randomized 1:1 to standard care vs. mechanical unloading by Impella-CP.
  5. The patients will be treated on a CCU with experience with use of Impella-CP.
  6. On the CCU, all patients will be monitored by a Swan-Ganz catheter for 48 hours.
  7. The pump speed will be adjusted to maintain the lowest tolerated PCWP while avoiding suction events.
  8. Mechanical unloading will last 36-48h. Afterwards, the Impella-CP will be explanted.
  9. All patients will receive standard pharmacotherapy of AMI, according to the guidelines.
  10. Revascularization of significant non-infarct lesions will be performed during the index hospitalization.
  11. 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.
  12. 3D-echocardiography and Tc-SPECT will be repeated at 3 months after the AMI.
  13. The patients will be followed by out-patient check-ups every 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Czechia
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Mechanical unloading
Mechanical unloading by Impella-CP for 36-48 hours, on top of the standard treatment
Procedure: LV mechanical unloading by Impella-CP
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:
  • Abiomed Impella-CP
No Intervention: Standard care
Standard treatment of AMI after PCI according to guidelines.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CV complications
Time Frame: during the first 5 day after AMI
occurence of TIMI bleeding, hemolysis, thromboembolic events
during the first 5 day after AMI
heart failure
Time Frame: during the first 5 day after AMI
acute heart failure requiring inotropes or progression of cardiogenic shock
during the first 5 day after AMI

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
self-assessed dyspnea
Time Frame: day 1, 2 and 5
dyspnea reported by the patient on a Likert scale
day 1, 2 and 5
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
diference in hs-TnT, BNP and lactate between the groups
during the first 5 day after AMI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute for Clinical and Experimental Medicine

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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