A clinical study to study the role of novel markers in acute myocardial infarction and its prognostic value

• Conditions: Acute myocardial infarction

• Registration Number: CTRI/2010/091/000489
• Lead Sponsor: Dr. Maddury Jyotsna, Associate Professor of Cardiology, Department of Cardiology, NIMS, Panjagutta, Hyderabad, A.P., India-500 082

Brief Summary

Myocardial infarction necessitates new therapeutic interventions, since it still results in high morbidity and mortality worldwide. Reperfusion therapy itself results in (acceleration of) apoptosis, called myocardial ischemia/reperfusion (I/R) injury. For several decades it is known that the inflammatory response during reperfusion is the major cause of myocardial I/R injury. Therapeutic options are limited by lack of (detailed) understanding of intra- and intercellular mechanisms between inflammatory cells and cardiomyocytes. Furthermore, clinical trials generally fail to reproduce experimental successes, because essential factors are not taken into account in animal studies: risk factor for coronary artery disease, duration of ischemia and reperfusion, time of intervention. Above all, there is no specific therapeutic target for inhibiting the inflammatory response, in which cardiomyocytes are involved. The identification of Toll-like receptors (TLRs), ST2 receptors (interleukin-1 receptor family member), heart type fatty acid-binding protein and Thrombus Precursor Protein from blood of patients with acute myocardial infarction (AMI) has given rise to, not only new insights on the inflammatory response initiated by cardiomyocytes themselves, but also provided potential targets to reduce myocardial I/R injury.STUDY OBJECTIVES:PrimaryTo see presence and levels of novel markers (toll like receptors, ST2 receptors which represent acute inflammation and Thrombus precursor protein and heart type fatty acid binding protein represent tissue necrosis) and genetic analysis for polymorphism in acute myocardial infarction and its prognostic significance. Secondary1.Mace -major cardiac events in hospital and at 30 days.2.Levels in relation to left ventricular function.Number of study subjects : 100SUBJECT ELIGIBILITYInclusion criteria: a.Patients with acute myocardial infarction ( ST MI) andb.Age group 20 to 80 years.Exclusion criteria:Patients who have significant underlying other systemic disorders lie chronic renal or hepatic or respiratory failure, malignancy and acute cerebrovascular accidents. Eligible patients of AMI after hospitalization treatment will be given as routine guide lines including primary angioplasty. Basal electrocardiogram and echocardiogram will be performed. At the time of putting vasofix itself blood samples will be drawn for complete blood picture including platelets, blood sugar, blood urea, serum electrolytes, cardiac enzymes, liver function tests, prothombin time, activated thromboplastin time, for toll like receptors levels, ST2 receptors levels , Thrombus precursor protein and heart type fatty acid binding protein will be taken. In CCMB by Dr. Radha the blood samples will be analyzed for above mentioned markers. On monocytes the expression of TLR4 protein and mRNA by flow cytometry (FCM) and real-time quantitative reverse transcription polymerase chain reaction (RT-PCR) will be done. Genomic DNA will be extracted from blood samples with the Puregene DNA isolation Kit (Gentra Systems, Minneapolis, MN) following the protocol of the manufacturer. Gene expression and Geno typing for the candidate genes for the detection of polymorphisms will be performed using PCR-RFLP methods. The PCR reactions will be performed in a Gradient Thermocycler. Each 20 µl of PCR mixture contained 100 ng DNA, 2 µl PCR buffer [50 mM KCl, 10 mM Tris-HCl (pH 9.0)], 1.5 mM MgCl2, 0.2 mM each of deoxynucleoside triphosphate, 0.5 mM of each primer, and 1 unit of TaqDNA polymerase. The reaction mixture will be initially denatured at 94°C for 3 min. For the polymorphisms studies, PCR will be performed in 30 cycles of 94°C for 45 s, 48°C -61°C for 45 s, and 72°C for 45 s. The PCR will be completed by a final extension cycle at 72°C for 7 min. The DNA fragments will be then separated using 3% agarose gel and detected by ethidium bromide staining. Quality-control samples will be included in various batches of samples assayed for the polymorphisms Patients will be followed in hospital and at 30 days for major cardiac events and repeat echocardiogram will be done at 30 days. fallow up is at 6 months and 1 year

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.patients with acute myocardial infarction(ST MI)2.Age group 20-80 years.

Exclusion Criteria

patients who have significant underlying other systemic disorders like chronic renal or hepatic or respiratory failure,malignancy and acute cerebrovascular accidents.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All Cause Mortality, Sudden Cardiac Death,Cardiogenic Shock, Significant Rhythm Arrhythmias,Left Ventricuclar Dysfucntion	1st Hour Of Myocardica Infarction To 48 Hours

Secondary Outcome Measures

Name	Time	Method
All Cause Mortality,MACE-Major Adverse Cardaic Events	one year

Trial Locations

Locations (1)

Department Of Cardiology; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Department Of Cardiology

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr.Maddury Jyotsna

Principal investigator

040-23300483

mail2jyotsna@rediffmail.com