Acute Coronary SyndromeNCT02755207
Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for suspected ACS patients at the emergency department (ED) and intensive care unit (ICU). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Suspected ACS patients (STEMI, NSTEMI, and UA)
Who may be able to join
- Suspected ACS patients (STEMI, NSTEMI, and UA):
- Age>18 years; Informed consent.
Who cannot join
- Patients who will undergo immediate PCI; Pregnant and 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.
bin he contact
huimin cao contact
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
Guangyu Chen, PhD, +86-02125076143, xinhuacru@163.com
About this study
The purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for suspected ACS patients at the emergency department (ED) and intensive care unit (ICU).
Read the detailed description
The present study is a single-center, prospective diagnostic study among patients presenting to the ED or ICU within 24 h of onset of chest pain suggestive of suspected ACS.
We propose to construct the biobank of ACS and evaluate the potential diagnostic value of circulating microRNAs compared with cTnI for suspected ACS patients. All the patients are to be followed up for 6 months. Final diagnosis was made by an expert panel cardiologist, based on all available clinical information including cTnI measurements, ECG, coronary angiography, cardiac exercise tests and information from hospital discharge letters.
The concentrations of microRNAs will be evaluated by quantitative reverse transcription PCR, using highly specific primers and hybridization probes.
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected ACS group | Patients admitted to the hospital with the diagnosis of ACS | |
| Blank control group | Patients admitted to the hospital without the diagnosis of ACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic value of microRNAs in qPCR，in ACS
Measured: Day 7
Secondary outcomes (1)
Evaluate the prognostic value of microRNAs in ACS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755207
- Sponsor's protocol ID
- XH-16-003
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2016
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02755207
- Acronym / sponsor ID
- XH-16-003
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- 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 purpose of this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for suspected ACS patients at the emergency department (ED) and intensive care unit (ICU).
Detailed description
The present study is a single-center, prospective diagnostic study among patients presenting to the ED or ICU within 24 h of onset of chest pain suggestive of suspected ACS.
We propose to construct the biobank of ACS and evaluate the potential diagnostic value of circulating microRNAs compared with cTnI for suspected ACS patients. All the patients are to be followed up for 6 months. Final diagnosis was made by an expert panel cardiologist, based on all available clinical information including cTnI measurements, ECG, coronary angiography, cardiac exercise tests and information from hospital discharge letters.
The concentrations of microRNAs will be evaluated by quantitative reverse transcription PCR, using highly specific primers and hybridization probes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected ACS group | – | –Patients admitted to the hospital with the diagnosis of ACS |
| Blank control group | – | –Patients admitted to the hospital without the diagnosis of ACS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Suspected ACS patients (STEMI, NSTEMI, and UA)
Key inclusion criteria (2 listed)
- Age>18 years; Informed consent.
Key exclusion criteria (1 listed)
- Patients who will undergo immediate PCI; Pregnant and 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.
Primary outcome
Evaluate the diagnostic value of microRNAs in qPCR，in ACS
Time frame: Day 7
1 secondary outcome
Evaluate the prognostic value of microRNAs in ACS
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
bin he contact
huimin cao contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 1 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 24 Feb 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 (hebinicu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the diagnostic value of microRNAs in qPCR，in ACS (time frame: Day 7). 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 24 Feb 2020.