Point-of-care device for testing Cardiac Troponin (I and T) for diagnosis of Acute Myocardial Infarction (AMI)
- Conditions
- Health Condition 1: I219- Acute myocardial infarction, unspecified
- Registration Number
- CTRI/2021/01/030318
- Lead Sponsor
- Rohit Srivastava
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 53
Leftover plasma from venous blood of suspected/ at-risk patients with ACS, COVID-19 and other conditions for which testing for cardiac troponins are requested by physicians.
a) Acute coronary syndrome
b) Acute respiratory infection
c) COVID-19
d) Pulmonary hypertension
e) Pulmonary embolus
f) Congestive heart failure
g) Coronary artery spasm
h) Tachyarrhythmias
i) Myocarditis
j) Kidney disease
k) Prolonged exercise
l) Trauma that injures the heart
m) Cardiomyopathy
n) Cardiac angioplasty/stenting
o) Heart defibrillation or electrical cardioversion
p) Open heart surgery
q) Radiofrequency ablation of the heart
r) Rhabdomyolysis and polymyositis
a) Patients not willing to participate in the study
b) Specimen prepared incorrectly
c) Those with labelling problems
d) Temperature not maintained for specimen.
e) Samples received >4 hours after collection.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To measure the ability of TropChek to detect cTnT and cTnI in the plasma and compared with Reference IVD.Timepoint: One-time
- Secondary Outcome Measures
Name Time Method 1 Diagnostic Sensitivity <br/ ><br>2 Diagnostic Specificity <br/ ><br>3 Positive Predictive Value <br/ ><br>4 Negative Predictive Value <br/ ><br>5 Likelihood Ratio <br/ ><br>6 Accuracy or probability of a correct test result. <br/ ><br>7 ReproducibilityTimepoint: One-time