Home SVCC Area: English - Español - Português
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,
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 .
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
2nd Virtual Congress of Cardiology
Dr. Florencio Garófalo
Dr. Raúl Bretal
Dr. Armando Pacher
Technical Committee - CETIFAC
Copyright© 1999-2001 Argentine Federation of Cardiology
All rights reserved
This company contributed to the Congress: