Acute Myocardial InfarctionNCT04390490
Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction
A study testing Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor in people with Acute Myocardial Infarction, run by Bin He at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Symptoms of chest pain
Who cannot join
- Patients who will undergo immediate PCI Pregnant
- Lactating women
- Patients with mental disorders
- Patients are using other experimental drugs; Refusal to provide informed.
Trial locations and contacts
1 site in 1 country.
China1 site
Ethics Committee of Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
About this study
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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensorDevice
Graphene quantum dots combined with Si nanowire is a new method of photoelectrochemical immunosensor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of photoelectrochemical immunosensor
Sensitivity，precision and cost of the photoeletrochemical immunosensor
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390490
- Sponsor's protocol ID
- XH-20-007
- Status last verified
- Aug 2020
- First submitted
- 9 May 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04390490
- Acronym / sponsor ID
- XH-20-007
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bin HeUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Automatic chemiluminescence analyzer will be used for dectecting the concentration of cardiac troponin I as control group. |
| Photoelectrochemical immunosensor | Experimental | Device: Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensorPhotoelectrochemical immunosensor will be used for dectecting the concentration of cardiac troponin I as test group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Symptoms of chest pain
Key exclusion criteria (4 listed)
- Patients who will undergo immediate PCI Pregnant
- Lactating women
- Patients with mental disorders
- Patients are using other experimental drugs; Refusal to provide informed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensorGraphene quantum dots combined with Si nanowire is a new method of photoelectrochemical immunosensor | Device | Photoelectrochemical immunosensor |
Primary outcome
Effectiveness of photoelectrochemical immunosensor
Time frame: 28 days
Sensitivity，precision and cost of the photoeletrochemical immunosensor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor in people with Acute Myocardial Infarction, run by Bin He at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin He, PhD (021-25077828, hebinicu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of photoelectrochemical immunosensor (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.