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Point-of-care device for testing Cardiac Troponin (I and T) for diagnosis of Acute Myocardial Infarction (AMI)

A Single-Center, Open-Label, Prospective, Clinical Validation Study of TROPCHEK â?? a Novel, Non-Invasive Class C In-Vitro Point-Of-Care Diagnostic Medical Device for detection of Cardiac Troponins T and I in the Venous Blood

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/01/030318
Enrollment
100
Registered
2021-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I219- Acute myocardial infarction, unspecified

Interventions

None listed

Sponsors

Rohit Srivastava
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
To measure the ability of TropChek to detect cTnT and cTnI in the plasma and compared with Reference IVD.Timepoint: One-time

Secondary

MeasureTime frame
1 Diagnostic Sensitivity 2 Diagnostic Specificity 3 Positive Predictive Value 4 Negative Predictive Value 5 Likelihood Ratio 6 Accuracy or probability of a correct test result. 7 ReproducibilityTimepoint: One-time

Countries

India

Contacts

Public ContactRohit Srivastava

IIT Bombay

rsrivasta@iitb.ac.in9867980408

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026