Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction

NCT ID: NCT04390490

Last Updated: 2020-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Photoelectrochemical immunosensor

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

Group Type EXPERIMENTAL

Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor

Intervention Type DEVICE

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

Interventions

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Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Symptoms of chest pain

Exclusion Criteria

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

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bin He

OTHER

Sponsor Role lead

Responsible Party

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Bin He

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ethics Committee of Xinhua Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Bin He, PhD

Role: CONTACT

021-25077828

Other Identifiers

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XH-20-007

Identifier Type: -

Identifier Source: org_study_id

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