Diagnostic accuracy of combination of HEART Pathway and 0- hour/1-hour hs-cTnT protocol for the prediction of MACE among acute chest pain

Not yet recruiting

Conditions: Non-ST elevation (NSTEMI) myocardial infarction,

Registration Number: CTRI/2023/06/053367

Lead Sponsor: JAMEEL A

Brief Summary: **AIIMS AND OBJECTIVES**

**Primary Objective:**

â€¢ To evaluate the diagnosticaccuracy of combination of 0-hour/1- hour hs-cTnT protocol and HEART Pathwayfor 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. Toutilize study findings in the disposal of acute chest pain patients coming tothe emergency department

**RESEARCH METHODOLOGY**

**Research approach**- Quantitative approach

**Research Design:** Prospective observational cohortresearch design

**Research Variables:** Diagnostic accuracy of combinationof 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 thanone lakh.

**Population:** Acute chest pain patients presentingto the emergency department.

**Sample and Sampling technique**:

Sample will be selected through purposivesampling technique.

**Sample size calculation**

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

Population size(for finite population correction factor orfpc)(*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 ofparticipants in follow-up, a total 350 chest pain patients will be enrolled inthe study.

**Data collection process**

Â·        Aftertaking formal permission to conduct the study, data for the study will becollected from December 2022- August 2023.

Â·        Checkthe eligibility of acute chest pain patients to enroll into study based on theeligibility criteria.

Â·        Informedwritten consent will be taken from the eligible participants.

Â·        Alongwith the routine medical history, physical examination and routineinvestigations, two venous blood samples will be collected at 0hr in yellowcolor serum tube and purple color EDTA tube.

Â·        EDTAtube will send to point of care laboratory situated inside the emergencydepartment for checking cardiac troponin I. Where cardiac troponin I will bechecked by using AQT90 FLEX immunoassay analyzer, which has limit ofdetection(LoD) of 0.010 mcg/L and upper reference limit (URL) of 0.023mcg/L.

Â·        Serumtube will send to smart lab situated in the new RAK OPD block for checkingHs-cTnT, where sample will be centrifuged and Hs-cTnT measurement will be performed with the Elecsyshigh-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.

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

Â·        Rulein, rule out and observation patients are identified by using ESC Hs-cTn 0h/1halgorithm.

Â·        TwoHEART score will be calculated by using 0hr Hs-cTnT and 0hr point of care cTnIvalues. HEAR components will be calculated based on the medical history and ECGfindings of the patient and will be same for both HEART scores.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

1.Patients (18years and older) with acute non traumatic chest pain admitted to the emergency departments.
2.Willingness to give consent.

Exclusion Criteria

1.STEMI patients 2.Cardiac arrest patients/ patients who received CPR 3.Chronic kidney disease patients.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): all india institute of medical science, new delhi
🇮🇳
South, DELHI, India
all india institute of medical science, new delhi
🇮🇳South, DELHI, India
jameel
Principal investigator
8700369348
jameel.akpza@gmail.com