Myocardial InfarctionUNLOAD-AMINCT04562272
Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
A study testing LV mechanical unloading by Impella-CP in people with Myocardial Infarction and Remodeling, Ventricular, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Remodeling, Ventricular, Shock, Cardiogenic
- What is being tested?
- LV mechanical unloading by Impella-CP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Sep 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 14059
Marek Sramko, MD, PhD, +420731682681, marek.sramko@ikem.cz
About this study
Official title: 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.
Read the 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.
- Being tested
- LV mechanical unloading by Impella-CP
- Keywords
- ventricular assist device, Impella, unloading
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV mechanical unloading by Impella-CPProcedure or surgery
Also called Abiomed 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)
| Study group | Role | What they receive |
|---|---|---|
| Mechanical unloading | Active comparator | Mechanical unloading by Impella-CP for 36-48 hours, on top of the standard treatment Receives: Procedure: LV mechanical unloading by Impella-CP |
| Standard care | No intervention | Standard treatment of AMI after PCI according to guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the left ventricular end-systolic volume
Absolute change in the LVESV measured by SPECT and compared between the groups
Measured: 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%
Measured: 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
Measured: LV scar extent measured during the index hospitalization (day 5-7) and at 3 months
Secondary outcomes (2)
CV complications
occurence of TIMI bleeding, hemolysis, thromboembolic events
Measured: during the first 5 day after AMI
heart failure
acute heart failure requiring inotropes or progression of cardiogenic shock
Measured: during the first 5 day after AMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start21 Sep 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marek Sramko, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562272
- Sponsor's protocol ID
- 15849/20
- Acronym
- UNLOAD-AMI
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuation of Post-infarct Remodeling in Patients With Acute Myocardial Infarction by Left Ventricular Mechanical Unloading Using Impella-CP
- ClinicalTrials.gov ID
- NCT04562272
- Acronym / sponsor ID
- UNLOAD-AMI / 15849/20
- Keywords
- ventricular assist device, Impella, unloading
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical unloading | Active comparator | Procedure: LV mechanical unloading by Impella-CPMechanical unloading by Impella-CP for 36-48 hours, on top of the standard treatment |
| Standard care | No intervention | –Standard treatment of AMI after PCI according to guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LV mechanical unloading by Impella-CPAlso: Abiomed Impella-CPThe patients will receive Impella-CP for 36-48 hours. The pump speed and LV unloading will be guided by PCWP (Swan-Ganz catheter) | Procedure or surgery | Mechanical unloading |
Primary outcome
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
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%
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
2 secondary outcomes
CV complications
Time frame: during the first 5 day after AMI
heart failure
Time frame: during the first 5 day after AMI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LV mechanical unloading by Impella-CP in people with Myocardial Infarction and Remodeling, Ventricular, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Sramko, MD, PhD (+420731682681, marek.sramko@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.