Back to resultsClinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction
Primary Purpose
Acute Myocardial Infarction
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Myocardial Infarction
Eligibility Criteria
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.
Sites / Locations
- Ethics Committee of Xinhua Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
Photoelectrochemical immunosensor
Arm Description
Automatic chemiluminescence analyzer will be used for dectecting the concentration of cardiac troponin I as control group.
Photoelectrochemical immunosensor will be used for dectecting the concentration of cardiac troponin I as test group.
Outcomes
Primary Outcome Measures
Effectiveness of photoelectrochemical immunosensor
Sensitivity，precision and cost of the photoeletrochemical immunosensor
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04390490
Brief Title
Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction
Official Title
Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bin He
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
Automatic chemiluminescence analyzer will be used for dectecting the concentration of cardiac troponin I as control group.
Arm Title
Photoelectrochemical immunosensor
Arm Type
Experimental
Arm Description
Photoelectrochemical immunosensor will be used for dectecting the concentration of cardiac troponin I as test group.
Intervention Type
Device
Intervention Name(s)
Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor
Intervention Description
Graphene quantum dots combined with Si nanowire is a new method of photoelectrochemical immunosensor
Primary Outcome Measure Information:
Title
Effectiveness of photoelectrochemical immunosensor
Description
Sensitivity，precision and cost of the photoeletrochemical immunosensor
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin He, PhD
Phone
021-25077828
Email
hebinicu@139.com
Facility Information:
Facility Name
Ethics Committee of Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction
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