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CTRI Number  CTRI/2010/091/000489 [Registered on: 18/08/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to study the role of novel markers in acute myocardial infarction and its prognostic value 
Scientific Title of Study   "Novel markers in acute myocardial infarction and its prognostic value" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
383/08  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Maddury Jyotsna 
Designation   
Affiliation   
Address  Associate professor of cardiology,Department of cardiology,
Nizam'sInstitute of Medical Sciences(NIMS),Punjagutta
Hyderabad
ANDHRA PRADESH
500 082
India 
Phone  040-23300483  
Fax  040-23300483  
Email  mail2jyotsna@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Maddury Jyotsna 
Designation   
Affiliation  Nizam'sInstitute of Medical Sciences(NIMS) 
Address  Associate professor of cardiology,Department of cardiology,
Nizam'sInstitute of Medical Sciences(NIMS),Punjagutta
Hyderabad
ANDHRA PRADESH
500 082
India 
Phone  040-23300483  
Fax  040-23300483  
Email  mail2jyotsna@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  R.N.V. Narendra Kumar 
Designation   
Affiliation   
Address  Department of Cardiology
Nizam'sInstitute of Medical Sciences(NIMS),Punjagutta
Hyderabad
ANDHRA PRADESH
500 082
India 
Phone  040-23300483  
Fax  040-23300483  
Email  narendrakumarrnv@gmail.com  
 
Source of Monetary or Material Support  
NIzam's Institute of Medical sciences(NIMS). punjagutta,hyderabad,A.P,INDIA-500 082  
 
Primary Sponsor  
Name  Dr. Maddury Jyotsna, Associate Professor of Cardiology, Department of Cardiology, NIMS, Panjagutta, Hyderabad, A.P., India-500 082 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
M/S Charan Medical Devices,no:502,chandra residecy,NavvenNagar,Bangara Hills Road No:1,Hyderabd-500 034,A.P,INDIA   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr.Maddury Jyotsna  Department Of Cardiology  NIMS, Panjagutta,Department of Cardiology-500 082
Hyderabad
ANDHRA PRADESH 
91-040-23300483
91-040-23300483
mail2jyotsna@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
council for clinical research and education,NIMS,hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Acute myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Blood sample collection   within six hours onset Acute myocardial infarction 
Comparator Agent  Blood sample collection of normal healthy subject  NIL 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1.patients with acute myocardial infarction(ST MI) 2.Age group 20-80 years 
 
ExclusionCriteria 
Details  patients who have significant underlying other systemic disorders like chronic renal or hepatic or respiratory failure,malignancy and acute cerebrovascular accidents 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
All Cause Mortality, Sudden Cardiac Death,Cardiogenic Shock, Significant Rhythm Arrhythmias,Left Ventricuclar Dysfucntion  1st Hour Of Myocardica Infarction To 48 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
All Cause Mortality,MACE-Major Adverse Cardaic Events  one year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/04/2009 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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: Primary To 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. Secondary 1. Mace -major cardiac events in hospital and at 30 days. 2. Levels in relation to left ventricular function. Number of study subjects : 100 SUBJECT ELIGIBILITY Inclusion criteria: a. Patients with acute myocardial infarction ( ST MI) and b. 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 
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