Dextran Use for Primary Angioplasty Protection in Acute Myocardial Infarction (DUPAP)

May 9, 2017 updated by: Centro Cardiovascular Salta

A Randomized Study to Evaluate Controlled Reperfusion With Venous Blood and Dextran for Myocardial Protection Compared With Standard Angioplasty During Primary Angioplasty in Patients With Acute Myocardial Infarction and TIMI 0/1 Flow.

Reperfusion therapy in acute myocardial infarction saves viable myocardium, but paradoxically reestablishment of coronary artery flow also induces damage and cell death, decreasing the full benefit of reperfusion in terms of reduction of infarct size and preservation of ventricular function . Myocardial reperfusion can in itself produce more damage and cell death, this process defines the phenomenon of reperfusion injury, which could be prevented by applying additional therapies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

During myocardial ischemia, due to lack of O2, the myocyte leaves energy production from the aerobic metabolism of lipids and the production of energy in the form of phosphates will depend, in this situation, on the anaerobic metabolism of glucose. As a result they are consumed muscle glycogen stores that produce little ATP, and also generating acidosis. The cell membrane loses its ability to maintain the fluid's electrolyte balance. Cellular edema is generated by the entry of sodium and water, leading to cell rupture. During ischemia and reperfusion free radicals are produced that stimulate inflammation and consequently release prothrombotic and cytotoxic substances that also produce cellular damage. Due to its osmotic, antithrombotic, anti-inflammatory and rheological effects, dextran could be useful in this scenario.

The administration of a solution in the distal bed, for the protection of the myocardium, before opening the epicardial artery is called by us "controlled reperfusion". The researchers think, using a solution with venous blood, containing less O2 but retaining buffer properties; enriched with Dextran, which has onctic power, anti-inflammatory and anticoagulant properties, and molecules similar to glucose; results in a potentially useful solution for myocardial protection in this scenario.

The group of investigators expect that controlled reperfusion treatment will reduce the incidence of ST correction and infarct size by 20-30%, improving the prognosis in terms of mortality and heart failure.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ricardo A Leon de la Fuente, MD
  • Phone Number: +543874034979
  • Email: ricaleon@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Women and men over 18 years of age
  • First acute myocardial infarction with ST elevation, within 6 hours of the initial symptoms, that are admitted for primary PCI at the Hospital San Bernardo.
  • TIMI 0 or 1 flow in the culprit artery.

Exclusion Criteria:

  • Not able or willing to give informed consent.
  • Participate in another protocol.
  • Pregnancy.
  • History of any of the diseases listed: cardiomyopathy, valvular disease severe, any disease with a life expectancy of less than 1 year.
  • Contraindication for protocol drugs (Dextran).
  • LBBB or pacemaker.
  • Prolonged cardiopulmonary resuscitation.
  • Cardiogenic shock.
  • Left main coronary lesion or culprit lesion in venous graft.
  • Large artery not feasible for PCI, guilty vessel of small caliber or very distal lesion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Reperfusion Primary Angioplasty
Patients admitted with acute myocardial infarction and TIMI flow 0/1, will be treated with the use of an intracoronary venous blood solution and dextran to protect the myocardium during reperfusion.
Procedure: Controlled Reperfusion

Patients will be treated in the occluded coronary with a solution of venous blood and Dextran, prior to the Stenting procedure.

Controlled Reperfusion PCI consists of crossing the culprit lesion with guidewire and then advancing a balloon (over the wire) to the distal segment of the culprit vessel. Proximal to the main distal branch, inflate the balloon to low atmospheres, remove the guide wire and inject the solution through the light of the balloon. Then reposition the guidewire, perform angioplasty as usual on the lesion. If there is a large residual thrombus load and at the operator's discretion, change the balloon by a manual thromboaspiration catheter and use it.

Then perform stenting of the lesion. The solution will be given with a 1 cc syringe as a slow bolus, controlling symptoms and ST segment response.

The compounds in solution are venous blood drawn from the patient after administration of heparin and mixed with dextran in a 3/1 ratio.
No Intervention: Standard Primary Coronary Angioplasty
Patients admitted with an acute myocardial infarction and TIMI flow 0/1, will be treated with primary angioplasty according to norms described in the international guidelines of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ST segment elevation from baseline
Time Frame: At six hours
Resolution of ST segment elevation in the EKG
At six hours
Total Mortality
Time Frame: One year
Incidence of death
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size
Time Frame: Six month
With the use of Myocardial Spect Imaging
Six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiovascular Salta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 052017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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