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Randomization in Clinical Trials of
Acute Myocardial Infarction Prolongs the
Time to Begin the Treatment of Reperfusion

Ramos, Hugo; Bianconi, Alejandro;
Giménez, Sandra; Rizzo, Nora;
Binci Vayer , Marina; Pahnke, Perla;
Olmedo, María; Díaz, María;
Lavasselli, Paula; Ortiz, Laura.

Servicio de Cardiología, Clínica Privada Caraffa, Area de
Emergencias Hospital de Urgencias de Córdoba,
Córdoba ,Argentina

Introduction: Treatment of Acute Myocardial Infarction (AMI) is dependent of time and randomization in clinical trials spend an extra time that infrequently is reported in results.

Objectives: To evaluate the time from door to reperfusion treatment in patients randomized in clinical trials of AMI.

Patients and method: 64 patients (p) were randomized in the following trials: PAMI III (Primary Angioplasty in Myocardial Infarction) [25 p] - HERO 2 (Hirulog Early Reperfusion Occlusion) [24 p] - GIK 2 (Glucose Insulin Potassium) [15 p]. The following intervals of time were prospectively recorded: Pain - Door (P-D); Door - 1stECG (D-1stECG); 1stECG - Randomization (1st ECG-Rand); Randomization - Streptokinase (Rand-STK); Randomization - Primary PTCA (Rand-PTCAp). Time spent in reading inform consent (IC), call to the coordinator center for randomization and preparation of drugs (STK, Hirulog, heparin, glucose-insulin-potasium infusion) were measured in a simulation. Time spent for search forms of trials, answer the questions of patients and his/her relatives following IC, calling for phone randomization and search for drugs of trials, were not recorded.

Results: See Table 1 and 2.



Conclusions: Sum of 1stECG-Rand + Rand-STK or 1stECG-Rand + Rand-PTCAp, spent 82 % and 88 % respectively of Door-STK or Door-PTCAp. These intervals generated from reading IC, answer questions from patients and his/her relatives, calling phone for randomization, searching and preparation of study drugs, prolongs the time recommended for Door to Drug or Door to PTCAp and it must be reduced without affect method and ethics of the trials.

 

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2nd Virtual Congress of Cardiology

Dr. Florencio Garófalo
Steering Committee
President
Dr. Raúl Bretal
Scientific Committee
President
Dr. Armando Pacher
Technical Committee - CETIFAC
President
fgaro@fac.org.ar
fgaro@satlink.com
rbretal@fac.org.ar
rbretal@netverk.com.ar
apacher@fac.org.ar
apacher@satlink.com

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