Analysis of the Efficacy of Cardiac Ischemic Postconditioning With New Clinical End-points Using Novel Biomarkers

Summary

The aim of the present study was to investigate the efficacy of ischemic postconditioning in acute myocardial infarction patients. The safety of patients enrolled in the study was ensured during the entire study. Over 18 years old men and women were enrolled in the study who arrived to 2 of the most acknowledged Hungarian cardiac centres due to acute myocardial infarction and fulfilled all inclusion and exclusion criteria as per protocol. Patients in the order of their arrival were assigned either to control or post conditioned groups by turns. Medical treatment of the control group was done according to standard Percutaneous Coronary Intervention (PCI) guidelines, i.e. there was no further intervention after artery opening for 8 minutes, then stenting was performed. In the post conditioned group, after reperfusion has been confirmed, the coronary artery was occluded by inflation of the stent balloon 4 times (for 1-1 minute) followed by 1-1-minute reperfusion repeatedly to induce ischemic postconditioning. Postconditioning procedure was followed by stenting as in the control group. All other interventions and treatments in both patient groups were identical according to guidelines.

Conditions

• Acute Myocardial Infarction With ST Elevation

Interventions

PROCEDURE

Postconditioning

The protocol of primary PCI followed by stenting is executed according to the descriptions according to the majority of relevant scientific literature on postconditioning studies and in accordance with the most recent guidelines. In the post conditioned group, after recanalization, the artery is occluded by inflation of stent balloon (4 times for 1-1 minute) followed by 1-1-minute reperfusion, repeatedly. Eight minutes after the start of examination, angiography is made in order to determine blood flow. Intervention is finished by the operator and another angiographic image is made (identical to initial standard projection).

DEVICE

Percutaneous coronary intervention

Percutaneous coronary intervention as per European Society of Cardiology guidelines.

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center

  collaborator OTHER

• Szeged University

  collaborator OTHER

• Peter Ferdinandy

  lead INDUSTRY

Principal Investigators

• Béla Merkely, MD, PhD · Heart and Vascular Center, Semmelweis University, Budapest

• Peter Ferdinandy, MD, PhD, MBA · Pharmahungary Group

• Imre Ungi, MD, PhD · University of Szeged, Faculty of Medicine, Cardiology Center, Department of Invasive Cardiology

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-14

Primary Completion

2018-10-15

Completion

2018-10-15

Countries

• Hungary

Study Locations