DUPAP: Dextran Use for Primary Angioplasty Protection in Acute Myocardial Infarction

Sponsor

Centro Cardiovascular Salta (Other)

Overall Status

Unknown status

CT.gov ID

NCT03148834

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction With ST Elevation	Procedure: Controlled Reperfusion	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Anticipated Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in ST segment elevation from baseline [At six hours]
Resolution of ST segment elevation in the EKG
Total Mortality [One year]
Incidence of death

Secondary Outcome Measures

Infarct size [Six month]
With the use of Myocardial Spect Imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centro Cardiovascular Salta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Centro Cardiovascular Salta

ClinicalTrials.gov Identifier:

NCT03148834

Other Study ID Numbers:

052017

First Posted:

May 11, 2017

Last Update Posted:

May 11, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centro Cardiovascular Salta

Acute Myocardial Infarction Reperfusion Injury

Additional relevant MeSH terms:

Myocardial Infarction

ST Elevation Myocardial Infarction

Infarction

Study Results

No Results Posted as of May 11, 2017