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Clinical Trials/CTRI/2021/01/030318
CTRI/2021/01/030318Other未知

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

Rohit Srivastava0 sites53 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
未知
Status
Other
Sponsor
Enrollment
53

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility 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

  • 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.

Investigators

Sponsor
Rohit Srivastava

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