Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP (NCT04562272) | Clinical Trial Compass
UnknownNot Applicable
Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
Czechia80 participantsStarted 2020-09-21
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in the left ventricular end-systolic volume
Timeframe: LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months
2
Occurrence of LV remodeling
Timeframe: LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months
3
Extent of post-infarct scar
Timeframe: LV scar extent measured during the index hospitalization (day 5-7) and at 3 months
Trial details
NCT IDNCT04562272
SponsorInstitute for Clinical and Experimental Medicine