The effect of timing of Heparin injection on the TIMI Flow grade in the STEMI patients undergoing primary PCI

The effect of timing of Heparin injection on the Thrombolysis in Myocardial Infarction (TIMI) Flow grade in the ST Elevation Myocardial Infarction (STEMI) patients undergoing primary Percutaneous Coronary Intervention (PCI)

This study is a Clinical trial with parallel groups, Phase 3, on 120 randomized patients.Subject are randomly assigned into two groups using the random block method with size 4. Random sequences will be generated using computer. After generating the list, a specific code will be assigned to each person. Registration and the sequence of random allocation is done by a third person. The sampling method is consecutive. Sampling is started based on the patients’ gradual referrals to the emergency and completed documents, and will be continued to reach the required sample size.

This study will be done in the Heshmat hospital of university of Guilan. Clinical data about myocardial infarction, coronary angiography and angioplasty will be gathered from completed medical documents. Clinical data about Left Ventricular Ejection Fraction (LVEF) and improvement in LVEF will be assessed after 40 days.

Inclusion criteria: Patients with ST Elevation Myocardial Infarction (STEMI ) who are willing to participate in this study The exclusion criteria : patients receiving thrombotic medicine during past seven days, pregnancy, active bleeding, thrombocytopenia history with heparin (HIT) , receiving heparin before hospitalization , thrombocytopenic patients, history of CABG, Age over 75 and failed PCI

Intervention group (bolus 90 u/kg IV heparin UFH in emergency) and Control group (bolus 90 u/kg IV heparin as hospital routine and during PCI).

Primary outcome : assessment of TIMI Flow grade

Subjects with eligible criteria are randomly assigned into two groups using the random block method with size 4. These patients will be divided into two groups: early heparin administration group in the emergency department, and late heparin administration group in the cath lab unit. Random sequences will be generated using computer. After generating the list, a specific code will be assigned to each person, and will be identified by it during the study. Registration and the sequence of random allocation is done by a third person. The sampling method is consecutive. Sampling is started based on the patients’ gradual referrals to the emergency department and completed documents, and will be continued to reach the required sample size.

Spss file will include all data about acute MI (onset of chest pain, duration of chest pain, anterior ,lateral, high lateral , extensive anterolateral, inferior, posterior, septal, RV MI) , LVEF during hospitalization, heart rate on the electrocardiogram, systolic and diastolic blood pressure, killip class , treatment group, Early Bolus heparin administration in emergency department and Late bolus heparin in the catch lab, and referring for CABG. Angiographic and angioplastic data including Identifiable culprit vessel, vascular access TIMI FLOW of culprit vessel: , LM،LAD،Diagonal، LCX، OM، RCA، PDA Before and after Primary PCI, HOSPITAL complications ( stent thrombosis, local side effects of angiography including bleeding and hematoma, ventricular tachyarrhythmia (VT,VF) Flail MV, Vntricular septal rupture , free wall rupture , pericardial effusion. Clinical data about LVEF 40 days after STEMI.

6 month after the results are published, the access period will be start.

Researchers working in academic and scientific institutions.

To obtain new results, researchers will be permitted to use further analysis and the data in the future researches.

Healthy Heart Research Center, Dr Heshmat heart hospital, Mosalla Square, Rasht, Guilan, Iran Phone number: 00981333664282 P.O.Box: 41939-55588 Fax: 00981333668718

A written request with sufficient detail should be sent to the postal address.After receiving the request, the scientific correspondence author will be responsive within one week.