NCT04390490

Brief Summary

The aim of this prospective randomized controlled clinical trial will evaluate the sensitivity, precision and effectiveness of photoelectrochemical immunosensor for early diagosis of acute myocardial infarction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

May 9, 2020

Last Update Submit

August 12, 2020

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of photoelectrochemical immunosensor

    Sensitivity，precision and cost of the photoeletrochemical immunosensor

    28 days

Study Arms (2)

control

NO INTERVENTION

Automatic chemiluminescence analyzer will be used for dectecting the concentration of cardiac troponin I as control group.

Photoelectrochemical immunosensor

EXPERIMENTAL

Photoelectrochemical immunosensor will be used for dectecting the concentration of cardiac troponin I as test group.

Device: Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor

Interventions

Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensorDEVICE

Graphene quantum dots combined with Si nanowire is a new method of photoelectrochemical immunosensor

Photoelectrochemical immunosensor

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Symptoms of chest pain

You may not qualify if:

  • Patients who will undergo immediate PCI Pregnant
  • Lactating women
  • Patients with mental disorders
  • Patients are using other experimental drugs; Refusal to provide informed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethics Committee of Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

Central Study Contacts

Bin He, PhD

CONTACT

021-25077828hebinicu@139.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 15, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2022

Study Completion

December 1, 2023

Last Updated

August 17, 2020

Record last verified: 2020-08

Locations

CN(1)