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Door To Unload


Title Door To Unloading with IMPELLA® CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study
Therapeutic Area Coronary Artery Disease
Principal Investigator Navin Kapur, MD
Min Age 21 Years
Max Age 80 Years
Gender All
Contact Vilma Casteneda, MD
617 636-7537
More Information https://clinicaltrials.gov/ct2/show/NCT03000270

Overview

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. 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 feasibility. The primary objective of this study is to evaluate whether the use of the Impella CP System for unloading of the left ventricle prior to PPCI has the potential to limit infarct size in patients presenting with STEMI. A secondary objective of the trial is to evaluate the need for 30 minutes of active left ventricular unloading prior to PPCI. Up to 50 subjects will be randomized int he study, 25 in each study arm.

Study Details

Inclusion Criteria

  • 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
  • Patient presents to catheterization laboratory between 1 hour and 6 hours of chest pain onset

Exclusion Criteria

  • Any cardioversion or cardiac arrest requiring CPR prior to enrollment
  • Administration of fibrinolytic therapy within 24 hours prior to enrollment
  • Cardiogeneic shock defneed as: systemic hypotension (systolic BP<90 mmHg or the need for inotropes/pressors to maintain a systolic BP>90mHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the cath lab, clinical evidence of end organ hypoprefusion, lactate level <2.5mmol/L

Study Requirements

In hospital care: Full physical examination including a neurological assessment, Routine and specialized cardiac blood tests (about 1-2 teaspoons).

3-5 days visit: Tests to measure your heart function: Electrocardiogram (ECG), cardiac magnetic resonance imaging (MRI), echocardiogram.

Follow-up will take place at 30 days and 90 days (±1 week)post PCI that includes a regular office visit and the following assessments: questions regarding subject health, physical exam, blood test (about 1-2 tablespoons), review of any adverse events, review of your medications, cardiac MRI (30 days only), echocardiogram (90 days only).

The total length of participation is 90 days ±1 week.