NCT04824716

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

5.8 years

First QC Date

March 8, 2021

Last Update Submit

April 19, 2021

Conditions

Acute Myocardial Infarction With ST Elevation

Keywords

ischemic postconditioningacute myocardial infarctionInvestigator Initiated Trialbiomarkercoronary artery diseaseischemicpostconditioninginfarctioninfarct sizearea at riskcoronary occlusionballoon catheterpercutaneous coronary interventionPCIMRI

Outcome Measures

Primary Outcomes (1)

  • Cardiac magnetic resonance imaging

    Left and right ventricular function, myocardial scar, transmurality, diffusion spectrum imaging (DSI) measurement and evaluation

    3 months after acute myocardial infarction

Secondary Outcomes (8)

  • Echocardiography measurement of Cardiac Ejection Fraction

    48 hours and 3 months after acute myocardial infarction

  • Echocardiography measurement of cardiac left ventricular segments for wall motion abnormalities

    48 hours and 3 months after acute myocardial infarction

  • Laboratory measurement of blood Nitrotyrosine levels.

    5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction

  • Laboratory measurement of blood MMP activity.

    5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction

  • Laboratory characterization of microRNA patterns with microRNA array

    5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction

  • +3 more secondary outcomes

Study Arms (2)

postconditioning

EXPERIMENTAL

Patients that underwent postconditioning after primary percutaneous coronary intervention.

Procedure: Postconditioning

control

OTHER

Patients that underwent primary percutaneous coronary intervention.

Device: Percutaneous coronary intervention

Interventions

PostconditioningPROCEDURE

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).

postconditioning
Percutaneous coronary interventionDEVICE

Percutaneous coronary intervention as per European Society of Cardiology guidelines.

control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be \>18 years of age
  • Myocardial infarction with elevated ST
  • Chest pain onset less than 12 hours before PCI
  • concordant ST elevation (\>0,1 mV) in at least 2 ECG leads
  • Occluded main proximal or middle main coronary ('Thrombolysis In Myocardial Infarction' flow grade: 0) diagnosed with coronarography
  • Coronary opened by PCI (TIMI 2 flow grade)
  • Awake, conscious, co-operating patient, who is able to retain his breath for 10 sec
  • Signed Patient Information Leaflet and Patient Informed Consent Form

You may not qualify if:

  • Cardiogenic shock
  • Previous myocardial infarction in the area of the occluded coronary artery
  • Occluded coronary with visible collateral branches
  • Lack of co-operation
  • Current left or right bundle branch block (LBBB)
  • Malignant ventricle arrhythmia or atrial fibrillation
  • Killip class \> 2
  • Known renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Heart and Vascular Center, Semmelweis University

Budapest, H-1122, Hungary

Location

Pharmahungary Group

Szeged, 6722, Hungary

Location

Department of Invasive Cardiology of Cardiology Center, Faculty of Medicine, University of Szeged

Szeged, H-6720, Hungary

Location

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionCoronary Artery DiseaseIschemiaInfarctionCoronary Occlusion

Interventions

Ischemic PostconditioningPercutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Béla Merkely, MD, PhD

    Heart and Vascular Center, Semmelweis University, Budapest

    PRINCIPAL INVESTIGATOR

  • Peter Ferdinandy, MD, PhD, MBA

    Pharmahungary Group

    STUDY DIRECTOR

  • Imre Ungi, MD, PhD

    University of Szeged, Faculty of Medicine, Cardiology Center, Department of Invasive Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 8, 2021

First Posted

April 1, 2021

Study Start

January 14, 2013

Primary Completion

October 15, 2018

Study Completion

October 15, 2018

Last Updated

April 21, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

HU(3)