Dextran Use for Primary Angioplasty Protection in Acute Myocardial Infarction
NCT ID: NCT03148834
Last Updated: 2017-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2017-06-01
2019-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Centro Cardiovascular Salta
OTHER
Responsible Party
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Central Contacts
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References
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Steg PG, Dabbous OH, Feldman LJ, Cohen-Solal A, Aumont MC, Lopez-Sendon J, Budaj A, Goldberg RJ, Klein W, Anderson FA Jr; Global Registry of Acute Coronary Events Investigators. Determinants and prognostic impact of heart failure complicating acute coronary syndromes: observations from the Global Registry of Acute Coronary Events (GRACE). Circulation. 2004 Feb 3;109(4):494-9. doi: 10.1161/01.CIR.0000109691.16944.DA. Epub 2004 Jan 26.
Velazquez EJ, Francis GS, Armstrong PW, Aylward PE, Diaz R, O'Connor CM, White HD, Henis M, Rittenhouse LM, Kilaru R, van Gilst W, Ertl G, Maggioni AP, Spac J, Weaver WD, Rouleau JL, McMurray JJ, Pfeffer MA, Califf RM; VALIANT registry. An international perspective on heart failure and left ventricular systolic dysfunction complicating myocardial infarction: the VALIANT registry. Eur Heart J. 2004 Nov;25(21):1911-9. doi: 10.1016/j.ehj.2004.08.006.
Hellermann JP, Jacobsen SJ, Redfield MM, Reeder GS, Weston SA, Roger VL. Heart failure after myocardial infarction: clinical presentation and survival. Eur J Heart Fail. 2005 Jan;7(1):119-25. doi: 10.1016/j.ejheart.2004.04.011.
Campo G, Valgimigli M, Gemmati D, Percoco G, Tognazzo S, Cicchitelli G, Catozzi L, Malagutti P, Anselmi M, Vassanelli C, Scapoli G, Ferrari R. Value of platelet reactivity in predicting response to treatment and clinical outcome in patients undergoing primary coronary intervention: insights into the STRATEGY Study. J Am Coll Cardiol. 2006 Dec 5;48(11):2178-85. doi: 10.1016/j.jacc.2005.12.085. Epub 2006 Nov 13.
Komamura K, Kitakaze M, Nishida K, Naka M, Tamai J, Uematsu M, Koretsune Y, Nanto S, Hori M, Inoue M, et al. Progressive decreases in coronary vein flow during reperfusion in acute myocardial infarction: clinical documentation of the no reflow phenomenon after successful thrombolysis. J Am Coll Cardiol. 1994 Aug;24(2):370-7. doi: 10.1016/0735-1097(94)90290-9.
Karila-Cohen D, Czitrom D, Brochet E, Faraggi M, Seknadji P, Himbert D, Juliard JM, Assayag P, Steg PG. Decreased no-reflow in patients with anterior myocardial infarction and pre-infarction angina. Eur Heart J. 1999 Dec;20(23):1724-30. doi: 10.1053/euhj.1999.1714.
Niccoli G, Lanza GA, Shaw S, Romagnoli E, Gioia D, Burzotta F, Trani C, Mazzari MA, Mongiardo R, De Vita M, Rebuzzi AG, Luscher TF, Crea F. Endothelin-1 and acute myocardial infarction: a no-reflow mediator after successful percutaneous myocardial revascularization. Eur Heart J. 2006 Aug;27(15):1793-8. doi: 10.1093/eurheartj/ehl119. Epub 2006 Jul 7.
Niccoli G, Giubilato S, Russo E, Spaziani C, Leo A, Porto I, Leone AM, Burzotta F, Riondino S, Pulcinelli F, Biasucci LM, Crea F. Plasma levels of thromboxane A2 on admission are associated with no-reflow after primary percutaneous coronary intervention. Eur Heart J. 2008 Aug;29(15):1843-50. doi: 10.1093/eurheartj/ehn325. Epub 2008 Jul 10.
Uyarel H, Cam N, Okmen E, Kasikcioglu H, Tartan Z, Akgul O, Simsek D, Cetin M, Bozbeyoglu E, Buturak A, Uzunlar B. Level of Selvester QRS score is predictive of ST-segment resolution and 30-day outcomes in patients with acute myocardial infarction undergoing primary coronary intervention. Am Heart J. 2006 Jun;151(6):1239.e1-7. doi: 10.1016/j.ahj.2006.03.019.
Buller CE, Fu Y, Mahaffey KW, Todaro TG, Adams P, Westerhout CM, White HD, van 't Hof AW, Van de Werf FJ, Wagner GS, Granger CB, Armstrong PW. ST-segment recovery and outcome after primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Circulation. 2008 Sep 23;118(13):1335-46. doi: 10.1161/CIRCULATIONAHA.108.767772. Epub 2008 Sep 8.
Bulluck H, Yellon DM, Hausenloy DJ. Reducing myocardial infarct size: challenges and future opportunities. Heart. 2016 Mar;102(5):341-8. doi: 10.1136/heartjnl-2015-307855. Epub 2015 Dec 16.
Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.
Other Identifiers
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052017
Identifier Type: -
Identifier Source: org_study_id
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