Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Detailed Description
-----------------
A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI. Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Official Title
-----------------
Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study

Conditions
-----------------
STEMI

Intervention / Treatment
-----------------
* Device: Impella unloading prior to PPCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Age 21-80 years First myocardial infarction Acute anterior STEMI with ≥ 2 mm in 2 or more contiguous anterior leads or≥ 4 mm total ST-segment deviation sum in the anterior leads Signed Informed Consent Main Exclusion Criteria: Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than 2.5mmol/L Inferior STEMI or suspected right ventricular failure Suspected or known pregnancy Suspected active infection History or known hepatic insufficiency prior to catheterization On dialysis therapy Known contraindication to: Undergoing MRI or use of gadolinium Heparin, pork, pork products or contrast media Receiving a drug-eluting stent Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prolonged unloading prior to PPCI<br>Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention | Device: Impella unloading prior to PPCI<br>* Impella unloading prior to PPCI<br>|
| Active Comparator: Immediate unloading prior to PPCI<br>Activation of Impella CP immediately prior to primary percutaneous coronary intervention | Device: Impella unloading prior to PPCI<br>* Impella unloading prior to PPCI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size at 30 Days | Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI | 30 Days | 
| MACCE at 30 Days | A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days: Cardiovascular mortality Re-infarction Stroke/TIA Major vascular complication | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct Characteristics - LV mass | Using CMR at 3-5 & 30 days, assessement of Infarct size as a percent of LV mass | 3 - 5 and 30 Days | 
| Infarct Characteristics - area at risk | Using CMR at 3-5 & 30 days, assessment of Infarct size as a percent of area (myocardium) at risk, | 3 - 5 and 30 Days | 
| 30 Day Safety Endpoint Rates | Event rate for All-cause mortality, Cardiovascular mortality, Re-infarction, Stroke/TIA, Vascular complications, Worsening heart failure or hemodynamic compromise requiring inotropic or hemodynamic support post Impella explant, Repeat revascularization, Aortic valve injury or dysfunction, Renal failure, Hemolysis, Hematoma, Bleeding, Thrombocytopenia | 30 Days | 
| Infarct Characteristics microvascular obstruction | Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO) | 3-5 and 30 Days | 
| Left Ventricular Function- LV end systolic and diastolic volume index | Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi & LVEDVi) | 3-5 and 30 Days | 
| Left Ventricular Function - Ejection Fraction | Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF) | 3-5 and 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Impella, Infarct Size, Unloading, Left Ventricle, PPCI, STEMI