Dextran Use for Primary Angioplasty Protection in Acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Acute Myocardial Infarction With ST Elevation

Intervention / Treatment
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* Procedure: Controlled Reperfusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Reperfusion Primary Angioplasty<br>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<br>* 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.<br>|
| No Intervention: Standard Primary Coronary Angioplasty<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myocardial Infarction Reperfusion Injury