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CTRI Number  CTRI/2012/12/003222 [Registered on: 14/12/2012] Trial Registered Retrospectively
Last Modified On: 10/12/2013
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   effect of platelet volume indices in one year outcome of MI patients 
Scientific Title of Study   Correlation of Platelet Volume Indices with Midterm prognosis in Acute Myocardial infarction with or without ST Elevation 
Trial Acronym  PLAMI 
Secondary IDs if Any  
Secondary ID  Identifier 
1  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MP RANJITH 
Designation  SENIOR RESIDENT 
Affiliation  DEPT.OF CARDIOLOGY, CALICUT GOVERNMENT MEDICAL COLLEGE 
Address  BHAVATRHARINI P.O.PANTHEERANKAVE KOZHIKODE KERALA
Medical College P.O Calicut - 673 008
Kozhikode
KERALA
673019
India 
Phone  9846382001  
Fax  914952355331  
Email  drranjithmp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MN KRISHNAN 
Designation  HEAD OF THE DEPARTEMENT 
Affiliation  DEPT.OF CARDIOLOGY, CALICUT GOVERNMENT MEDICAL COLLEGE 
Address  DEPT. OF CARDIOLOGY CALICUT MEDICAL COLLEGE, CALICUT
Medical College P.O Calicut - 673 008
Kozhikode
KERALA
673008
India 
Phone  9846382001  
Fax  914952355331  
Email  kedaram@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MP RANJITH 
Designation  SENIOR RESIDENT 
Affiliation  DEPT.OF CARDIOLOGY, CALICUT GOVERNMENT MEDICAL COLLEGE 
Address  BHAVATRHARINI P.O.PANTHEERANKAVE KOZHIKODE KERALA
Medical College P.O Calicut - 673 008
Kozhikode
KERALA
673019
India 
Phone  9846382001  
Fax  914952355331  
Email  drranjithmp@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  none 
Address  not applicable 
Type of Sponsor  Other [none] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ranjith MP  Department of cardiology and medicine  Medical College P.O Calicut-67308
Kozhikode
KERALA 
9846382001
04952432606
drranjithmp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GOVT. MEDICAL COLLEGE ,KOZHIKODE,INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Month(s)
Gender  Both 
Details  All patients admitted to Calicut medical college in the study period (1 year) with a diagnosis of ST elevation MI or Non ST elevation MI.
ST elevation MI defined as patients with typical chest pain and ECG showing ST elevation. Non ST elevation MI defined as patients with typical chest pain, no ST elevation in ECG and with elevated biochemical markers of cardiac necrosis.
 
 
ExclusionCriteria 
Details  1. Patients whose platelet indices could not be estimated within 12 hours of presentation.
2. Patients with bleeding disorders, preeclampsia, sepsis or with history of recent blood transfusion.
3. Patients who are receiving drugs which can cause thrombocytopenia.
4. Patients with recent history of major operation or trauma.
5. Previous myocardial infarction in 6 months
6. Severe noncardiac illness limiting survival less than 1year
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A composite of death due to any cause, non fatal myocardial infarction and non fatal cerebrovascular accident at one year follow up.  The primary outcomes are assessed at first hospital admission, than at 3 month, 6 month, 9 month and 12 month follow up period 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome:
1) In hospital mortality.
2) A Composite of cardiovascular mortality, non fatal MI, hospitalization for heart failure or documented cardiac tachy or bradyarrhythmia in survivors to discharge in the one year follow up period.
 
1year 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/10/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Platelets play a key role in the pathophysiology of acute coronary syndromes (ACS). Many studies have looked in to various characteristics of platelets in patients presenting with ACS. Many of the studies were on platelet count and mean platelet volume. They have clearly established that platelet count is decreased and mean platelet volume is elevated among patients presenting with ACS. The most accepted explanation for this is the consumption of platelets and release of larger and more immature platelets from marrow in to the circulation. According to recent studies larger platelets are enzymatically and metabolically more active and have a higher potential thrombosis ability compared to smaller ones. The degree of reduction in platelet count and increase in platelet size may denote the extent of platelet consumption and may correlate with the extent of infarction. So these parameters may correlate with both short and long term prognosis after an ACS. Studies have shown conflicting results in this regard. Several studies have shown good correlation of platelet indices with in hospital outcomes, 6 month outcomes as well as 2 year outcomes. But few studies have shown no correlation between platelet indices and 6 month outcome in NSTEACS.The studies looking in to utility of these parameters for prognostication of patients after ACS are absent.

AIMS  

1)      To study the correlation of platelet volume indices (mean platelet volume, platelet distribution width and platelet large cell ratio) at the time of presentation with 1 year Major adverse cardiac events among patients with acute myocardial infarction with or without ST elevation.

 

2)      To study the serial changes in these indices at three months in patients with abnormal platelet volume indices at presentation and to correlate it with short term major adverse cardiac events.

METHODOLOGY

Study is planned as a prospective cohort study.

Inclusion criteria:

All patients admitted to Calicut medical college in the study period (1 year) with a diagnosis of ST elevation MI or Non ST elevation MI.

ST elevation MI defined as patients with typical chest pain and ECG showing ST elevation. Non ST elevation MI defined as patients with typical chest pain, no ST elevation in ECG and with elevated biochemical markers of cardiac necrosis.

Exclusion criteria:

1.      Patients whose platelet indices could not be estimated within 12 hours of presentation.

2.      Patients with bleeding disorders, preeclampsia, sepsis or with history of recent blood transfusion.

3.      Patients who are receiving drugs which can cause thrombocytopenia.

4.      Patients with recent history of major operation or trauma.

5.      Previous myocardial infarction in 6 months

6.      Severe noncardiac illness limiting survival less than 1year

Baseline evaluation:

Data to be collected regarding demographic characteristics, conventional CAD risk factors, ECG manifestations, Killip class at presentation TIMI score and biochemical values. Before discharge, data to be collected regarding in hospital events, pre discharge Ejection fraction and details of CAG and revascularization if patient has undergone any procedure.

FOLLOW UP

Follow up is planned at one month after discharge then at 3 months and subsequently every 3 months for a period of one year. In patients with any of the three indices abnormal at admission, all the three parameters are repeated at the follow up visit at 3 months. During follow up period, data is to be collected regarding medications, compliance to medications and smoking, details of CAG and revascularization if patient has undergone, mortality and cause of death and clinical events including recurrent acute coronary syndrome, heart failure hospitalizations, hospitalization for documented cardiac arrhythmia

ANALYSIS

Primary outcome:  A composite of death due to any cause, non fatal myocardial infarction and non fatal cerebrovascular accident at one year follow up.

Secondary outcome:

1) In hospital mortality.

2) A Composite of cardiovascular mortality, non fatal MI, hospitalization for heart failure or documented cardiac tachy or bradyarrhythmia in survivors to discharge in the one year follow up period.

Cardiovascular mortality is defined as any unexplained sudden death or in hospital death after admission with a diagnosis of acute coronary syndrome, cardiac failure, cardiacarrhythmia or cerebrovascular accident.

 

 

 

Each of the platelet indices at admission Mean platelet volume, platelet distribution width and platelet large cell ratio are to be correlated with primary outcome and each of the secondary outcomes.

In patients with any of the indices abnormal at presentation that parameter to be repeated at 3 months and patients are grouped in to those with normalized values and persistently abnormal values. Differences in primary outcome to be analyzed in these two groups.



 
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