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CTRI Number  CTRI/2023/06/053367 [Registered on: 01/06/2023] Trial Registered Prospectively
Last Modified On: 31/05/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Diagnostic accuracy of combination of HEART Pathway and 0- hour/1-hour hs-cTnT protocol for the prediction of MACE among acute chest pain  
Scientific Title of Study   An observational cohort study to assess the diagnostic accuracy of combination of HEART Pathway and 0- hour/1-hour high sensitivity cardiac troponin T (hs-cTnT) protocol for the prediction of MACE (major adverse cardiac events) among acute chest pain patients presenting to the emergency department. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JAMEEL A 
Designation  NURSING OFFICER 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE 
Address  NIS,ROOM NO 5, COMPUTER FACILITY, MAIN AIIMS

South West
DELHI
110029
India 
Phone  8700369348  
Fax    
Email  jameel.akpza@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  JAMEEL A 
Designation  NURSING OFFICER 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE 
Address  NIS,ROOM NO 5, COMPUTER FACILITY, MAIN AIIMS

South
DELHI
110029
India 
Phone  8700369348  
Fax    
Email  jameel.akpza@gmail.com  
 
Details of Contact Person
Public Query  
Name  JAMEEL A 
Designation  NURSING OFFICER 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE 
Address  NIS, ROOM NO 5, COMPUTER FACILITY, MAIN AIIMS

South
DELHI
110029
India 
Phone  8700369348  
Fax    
Email  jameel.akpza@gmail.com  
 
Source of Monetary or Material Support  
Department of emergency medicine, AIIMS, New delhi 
 
Primary Sponsor  
Name  JAMEEL A 
Address  NIS, MAIN AIIMS, NEW DELHI-110029 
Type of Sponsor  Other [INVESTIGATOR INITIATED PROJECT] 
 
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 
jameel  all india institute of medical science, new delhi  EM 1, DEPARTMENT OF EMERGENCY MEDICINE
South
DELHI 		 8700369348

jameel.akpza@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALL INDIA INSTITUTE OF MEDICAL SCIENCE, NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I214||Non-ST elevation (NSTEMI) myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients (18years and older) with acute non traumatic chest pain admitted to the emergency departments.
2.Willingness to give consent.
 
 
ExclusionCriteria 
Details  1.STEMI patients
2.Cardiac arrest patients/ patients who received CPR
3.Chronic kidney disease patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnostic performance to rule in and rule out MACE at index emergency visit by HEART pathway, 0-hr/1-hr hs-cTn protocol and combination of HEART pathway with 0-hr/1-hr hs-cTn protocol  At index emergency visit 
 
Secondary Outcome  
Outcome  TimePoints 
1. Prognostic performance of HEART pathway, 0-hr/1-hr hs-cTn protocol and combination of HEART pathway with 0-hr/1-hr hs-cTn protocol to predict MACE at 30days follow up.  At 30 days follow up 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   01/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

AIIMS AND OBJECTIVES

Primary Objective:

• To evaluate the diagnostic accuracy of combination of 0-hour/1- hour hs-cTnT protocol and HEART Pathway for the prediction of MACE in acute chest pain patients.

Secondary Objectives:

  1. To evaluate diagnostic accuracy of HEART pathway for prediction of MACE in acute chest pain patients.
  2. To evaluate diagnostic accuracy of 0-hr/1-hr hs-cTn protocol for prediction of MACE in acute chest pain patients.
  3. To compare the diagnostic accuracy of point of care cardiac troponin (cTn) assays and automated/central laboratory hs-cTn assays for predicting MACE.
  4. To utilize study findings in the disposal of acute chest pain patients coming to the emergency department

RESEARCH  METHODOLOGY

Research approach- Quantitative approach

Research Design: Prospective observational cohort research design

Research Variables: Diagnostic accuracy of combination of HEART pathway and 0-hr/1-hr hs-cTn protocol

Setting: Emergency department of AIIMS New Delhi. AIIMS is a tertiary care center with an average annual ED visit of more than one lakh.

Population: Acute chest pain patients presenting to the emergency department.

Sample and Sampling technique:

 Sample will be selected through purposive sampling technique.

 

Sample size calculation

Sample size n = [DEFF*Np(1-p)]/ [(d2/Z21-α/2*(N-1)+p*(1-p)] 

Population size(for finite population correction factor or fpc)(N): 1000000

Hypothesized % frequency of outcome factor in the population (p): 30%+/-5

Confidence limits as % of 100(absolute +/- %)(d): 5%

Design effect (for cluster surveys-DEFF): 1

At 95% confidence level the calculated sample size is 323. By considering attrition of participants in follow-up, a total 350 chest pain patients will be enrolled in the study.

Data collection process

·         After taking formal permission to conduct the study, data for the study will be collected from December 2022- August 2023.

·         Check the eligibility of acute chest pain patients to enroll into study based on the eligibility criteria.

·         Informed written consent will be taken from the eligible participants.

·         Along with the routine medical history, physical examination and routine investigations, two venous blood samples will be collected at 0hr in yellow color serum tube and purple color EDTA tube.

·         EDTA tube will send to point of care laboratory situated inside the emergency department for checking cardiac troponin I. Where cardiac troponin I will be checked by using AQT90 FLEX immunoassay analyzer, which has limit of detection(LoD) of 0.010 mcg/L and upper reference limit (URL) of 0.023mcg/L.

·         Serum tube will send to smart lab situated in the new RAK OPD block for checking Hs-cTnT, where sample will be centrifuged and Hs-cTnT measurement will be performed with the Elecsys high-sensitivity Troponin T assay on the cobas e801 system (Roche Diagnostics, Basel,Switzerland), which has a limit of detection of 5 ng/L and upper reference limit (URL) of 14ng/L.

·         Another sample will take in serum tube at 1hr of arrival to check Hs-cTnT.

·         Rule in, rule out and observation patients are identified by using ESC Hs-cTn 0h/1h algorithm.

·         Two HEART score will be calculated by using 0hr Hs-cTnT and 0hr point of care cTnI values. HEAR components will be calculated based on the medical history and ECG findings of the patient and will be same for both HEART scores.

·         MACE will be assessed for the index ED visit and patients will be followed up to 1 month for checking MACE at 1 month.



 
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