Clinical trial NCT04562272: Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
Official title: Attenuation of Post-infarct Remodeling in Patients With Acute Myocardial Infarction by Left Ventricular Mechanical Unloading Using Impella-CP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Remodeling, Ventricular
Shock, Cardiogenic
Keywords: ventricular assist device
Impella
unloading
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2020-09-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
measure: Occurrence of LV remodeling
timeFrame: LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months
measure: Extent of post-infarct scar
timeFrame: LV scar extent measured during the index hospitalization (day 5-7) and at 3 months
Secondary outcomes:
measure: CV complications
timeFrame: during the first 5 day after AMI
measure: heart failure
timeFrame: during the first 5 day after AMI
Other outcomes:
measure: self-assessed dyspnea
timeFrame: day 1, 2 and 5
measure: lung water
timeFrame: day 1, 2 and 5
measure: maximum hs-TnT, BNP, serum lactate
timeFrame: during the first 5 day after AMI
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
Study officials:
References: