Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP

Myocardial Infarction Clinical Trial

— UNLOAD-AMI  

Official title:

Attenuation of Post-infarct Remodeling in Patients With Acute Myocardial Infarction by Left Ventricular Mechanical Unloading Using Impella-CP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04562272
• Other study ID #: 15849/20
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2020
• Source: Institute for Clinical and Experimental Medicine
• Contact: Marek Sramko, MD, PhD
• Phone: +420731682681
• Email: marek.sramko[@]ikem.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Remodeling, Ventricular
• Shock, Cardiogenic
• Ventricular Remodeling

Intervention

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)

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine (IKEM)	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	self-assessed dyspnea	dyspnea reported by the patient on a Likert scale	day 1, 2 and 5
Other	lung water	assessment of lung water score by ultrasound	day 1, 2 and 5
Other	maximum hs-TnT, BNP, serum lactate	diference in hs-TnT, BNP and lactate between the groups	during the first 5 day after AMI
Primary	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
Primary	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
Primary	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	CV complications	occurence of TIMI bleeding, hemolysis, thromboembolic events	during the first 5 day after AMI
Secondary	heart failure	acute heart failure requiring inotropes or progression of cardiogenic shock	during the first 5 day after AMI