NCT04562272

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

2.3 years

First QC Date

September 20, 2020

Last Update Submit

September 20, 2020

Conditions

Myocardial InfarctionRemodeling, VentricularShock, Cardiogenic

Keywords

ventricular assist deviceImpellaunloading

Outcome Measures

Primary Outcomes (3)

  • Difference in the left ventricular end-systolic volume

    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

    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

    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 Outcomes (2)

  • CV complications

    during the first 5 day after AMI

  • heart failure

    during the first 5 day after AMI

Other Outcomes (3)

  • self-assessed dyspnea

    day 1, 2 and 5

  • lung water

    day 1, 2 and 5

  • maximum hs-TnT, BNP, serum lactate

    during the first 5 day after AMI

Study Arms (2)

Mechanical unloading

ACTIVE COMPARATOR

Mechanical unloading by Impella-CP for 36-48 hours, on top of the standard treatment

Procedure: LV mechanical unloading by Impella-CP

Standard care

NO INTERVENTION

Standard treatment of AMI after PCI according to guidelines.

Interventions

LV mechanical unloading by Impella-CPPROCEDURE

The patients will receive Impella-CP for 36-48 hours. The pump speed and LV unloading will be guided by PCWP (Swan-Ganz catheter)

Also known as: Abiomed Impella-CP
Mechanical unloading

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14059, Czechia

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionVentricular RemodelingShock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, AnatomicalShock

Central Study Contacts

Marek Sramko, MD, PhD

CONTACT

+420731682681marek.sramko@ikem.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Acute Cardiology

Study Record Dates

First Submitted

September 20, 2020

First Posted

September 24, 2020

Study Start

September 21, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

September 24, 2020

Record last verified: 2020-09

Locations

CZ(1)