Design and implementation of the TRACIA: intracoronary autologous transplant of bone marrow-derived stem cells for acute ST elevation myocardial infarction.

OBJECTIVE: To describe the design of a protocol of intracoronary autologous transplant of bone marrow-derived stem cells for acute ST-elevation myocardial infarction (STEMI) and to report the safety of the procedure in the first patients included. METHODS: The TRACIA study was implemented following predetermined inclusion and exclusion criteria. The protocol includes procedures such as randomization, bone marrow retrieval, stem cells processing, intracoronary infusion of stem cells in the infarct-related artery, preand- post MRI, pre-and-post SPECT with radioisotope ventriculography, and clinical follow-up at 6 months. RESULTS: Eight patients with a diagnosis of acute STEMI and duration of symptoms of ?24 hours that were perfused successfully through primary percutaneous coronary intervention (PPCI) with a LVEF of ?45% were assigned randomly to two groups (n = 4 each). One group treated with stem cells and the other corresponded to the control group. Neither death, re-infarction, no need for revascularization or thrombosis of the stent were observed at follow-up. CONCLUSIONS: The initial experience at the Instituto Nacional de Cardiología Ignacio Chávez in the treatment of acute STEMI by means of autologous transplantation of bone marrow-derived stem cells is encouraging. Implementation was possible in the first eight patients with no complications.

Design and implementation of the TRACIA: intracoronary autologous transplant of bone marrow-derived stem cells for acute ST elevation myocardial infarction / Diseño e implementación del estudio TRACIA: Trasplante intracoronario Autológo de Células madre para Infarto Agudo del miocardio con elevación de segmento ST

Objective: To describe the design of a protocol of intracoronary autologous transplant of bone marrow-derived stem cells for acute ST-elevation myocardial infarction (STEMI) and to report the safety of the procedure in the first patients included. Methods: The TRACIA study was implemented following predetermined inclusion and exclusion criteria. The protocol includes procedures such as randomization, bone marrow retrieval, stem cells processing, intracoronary infusion of stem cells in the infarct-related artery, pre-and-post MRI, pre-and-post SPECT with radioisotope ventriculography, and clinical follow-up at 6 months. Results: Eight patients with a diagnosis of acute STEMI and duration of symptoms of <24 hours that were perfused successfully through primary percutaneous coronary intervention (PPCI) with a LVEF of <45% were assigned randomly to two groups (n = 4 each). One group treated with stem cells and the other corresponded to the control group. Neither death, re-infarction, no need for revascularization or thrombosis of the stent were observed at follow-up. Conclusions: The initial experience at the Instituto Nacional de Cardiología Ignacio Chávez in the treatment of acute STEMI by means of autologous transplantation of bone marrow-derived stem cells is encouraging. Implementation was possible in the first eight patients with no complications.

Objetivo: Describir el diseño y la implementación de un protocolo de transplante autólogo intracoronario de células madre derivadas de médula ósea en infarto agudo al miocardio con elevación del ST y reportar la seguridad del procedimiento en los primeros pacientes incluidos. Métodos: El estudio TRACIA se implementó con base en criterios de inclusión y exclusión predeterminados. El protocolo incluye la aleatorización, obtención de médula ósea, procesamiento de células madre, infusión intracoronaria de células madre, RM basal y al seguimiento, SPECT con ventriculografía radioisotópica basal y post-procedimiento, y seguimiento clínico a seis meses. Resultados: Ocho pacientes con diagnóstico de infarto agudo del miocardio con elevación del ST y duración de síntomas <24 horas que fueron reperfundidos exitosamente con angioplastia primaria y con fracción de expulsión <45%, fueron aleatorizados a dos grupos; uno de ellos fue tratado con células madre y el otro grupo permaneció como control. No se observó muerte, re-infarto, necesidad de revascularización o trombosis del Stent durante el seguimiento. Conclusiones: La experiencia inicial en el Instituto Nacional de Cardiología Ignacio Chávez en el tratamiento del infarto agudo del miocardio con elevación del ST mediante trasplante autólogo de células madre derivadas de médula ósea, es alentadora. La implementación sin complicaciones fue posible en los primeros ocho pacientes.

Detection of myocardial viability could be improved by rest GIK (glucose-insulin-potassium solution)-Tc 99m sestamibi compared with TL-201 reinjection, in post myocardial infarction patients.

UNLABELLED: GIK solutions improve detection of myocardium viability after acute infarction because they could change the metabolic conditions, improving myocardial perfusion defects. METHODS AND RESULTS: Seventy four patients (52 men, 22 women, mean age 53.3.08 +/- 12.14 years) with previous myocardial infarction (evolution time, 4.2 +/- 3.1 months) underwent pharmacological stress (dipyridamole), rest redistribution and reinjection Tl-201 image as well rest/stress Tc-99m Sestamibi, after the intravenous administration of GIK (200 g glucose +/- 30 UI regular insuline +/- 40 mEq potassiumchloride/500 mL in continuous infusion during 3 hours), Group A (N = 22) or oral administration of 70 g of glucose+/- 40 mEq of potassium chloride taking in advantage the endogenous insulin secretion, to non-diabetic patients (group B = GB, N = 26) and group C (GC, diabetic patients N = 26). All of the 74 patients received 10 mg of sublingual Isorbide previous to 25 mCi of Tc99m Sestamibi administration in a different 2 days protocol. A total of 1,480 myocardial segments were assessed and numbered, and the severity of perfusion defects in the segments involved, were compared between Thallium 201 rest reinjection and GIK-MIBI as the main objective of the study. Involved territories number: 4.02 +/- 2.50 vs. 6.88 +/- 2.12, p = 0.005 for AD; 5.2 +/- 1.44 vs. 6.35 +/- 1.11, p = 0.05 for RC and 1.58 +/- 1.01 vs. 2.05 +/- 1.05, p = 0.05 Cx. For GIK-MIBI vs. Tl-201 reinjection respectively, and defect severity: 8.2 +/- 6.04 vs. 13.22 +/- 5.38, p = 0.01 for LAD; 11.72 +/- 5.08 vs. 15.13 +/- 4.42, p = 0.005 for RC and 2.66 +/- 2.09 vs. 4.69 +/- 3.58, p = 0.003 Cx . For GIK-MIBI vs. Tl-201 reinjection respectively, were found. CONCLUSION: Our data suggest that GIK-MIBI protocol is a safe and easy procedure which improves the detection of perfusion reversible defects compared with Tl-201 reinjection, obtaining better information regarding myocardial viability, with lower acquisition time and less cost.