Acute Myocardial InfarctionNCT05266547
Impact of OCT on Outcomes in AMI
An observational study of Acute Myocardial Infarction, run by Beijing Luhe Hospital at 1 site in China.
Trial summary
This protocol describes a retrospective, single-center study intended to test the impact of optical coherence tomography(OCT) on long term clincical outcomes in patients with acute myocardial infarction(AMI). All the patients will be followed by intracoronary OCT at medium follow-up of 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- OCT guided coronary intervention
- Type of treatment
- Medical device
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 1 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this retrospective study, all the patients ≥18yesrs with AMI enrolled was devided into 2 groups, the primary endpoint will be major adverse cardiovascular events at least 3 years clinical follow up.
Who may be able to join
- Age≥18 years old
- Patients undergo cardiac catheterization and percutaneous coronary intervention(PCI) for AMI(STEMI or NSTEMI) ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction, symptoms onset≤ 24h.NSTEMI was defined as elevated troponin levels and the absence of ST elevation at the time of diagnosis, PCI was performed within 24hours after symtoms onset.
- Sufficient quality of the OCT recording allowing for CoreLab analysis.
Who cannot join
- ostial of Left main disease
- Cardiogenic shock or severe hemodynamic instability
- Severe renal insufficiency (creatinine clearance ≤30 mL/min)
- Bacteraemia or septicaemia
- Severe coagulation disorders
- Patients with life expectancy less than 1 year
- Patients who refuse to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Luhe Hospital
Beijing, 100000
Jincheng Guo, M.D., 8610-13521968844
About this study
Official title: Impact of Optical Coherence Tomography on Long-term Clincal Outcomes in Patients With Acute Myocardial Infarction
This protocol describes a retrospective, single-center study intended to test the impact of optical coherence tomography(OCT) on long term clincical outcomes in patients with acute myocardial infarction(AMI). All the patients will be followed by intracoronary OCT at medium follow-up of 3 years.
- Conditions
- Acute Myocardial Infarction
- Being tested
- OCT guided coronary intervention
- Keywords
- Tomography, Optical Coherence, STEMI, NSTEMI, Major adverse cardiovascular event
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT guided coronary interventionDevice
patients were divided into two groups,on OCT guided coronary group and coronary angiography guided group
| Study group | Role | What they receive |
|---|---|---|
| OCT guided group | Not described Receives: Device: OCT guided coronary intervention | |
| angiography guided group | Not described Receives: Device: OCT guided coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular event
including cardiovascualr death, myocardial infarction, and target lesion revascularization, target vessel revascularization
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Jan 2016
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Luhe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jincheng Guo, Beijing Luhe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266547
- Sponsor's protocol ID
- BeijngLH
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Optical Coherence Tomography on Long-term Clincal Outcomes in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05266547
- Acronym / sponsor ID
- BeijngLH
- Conditions
- Acute Myocardial Infarction
- Keywords
- Tomography, Optical Coherence, STEMI, NSTEMI, Major adverse cardiovascular event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Beijing Luhe HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 4 Mar 2022 (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.
This protocol describes a retrospective, single-center study intended to test the impact of optical coherence tomography(OCT) on long term clincical outcomes in patients with acute myocardial infarction(AMI). All the patients will be followed by intracoronary OCT at medium follow-up of 3 years.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT guided group | – | Device: OCT guided coronary intervention |
| angiography guided group | – | Device: OCT guided coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this retrospective study, all the patients ≥18yesrs with AMI enrolled was devided into 2 groups, the primary endpoint will be major adverse cardiovascular events at least 3 years clinical follow up.
Key inclusion criteria (3 listed)
- Age≥18 years old
- Patients undergo cardiac catheterization and percutaneous coronary intervention(PCI) for AMI(STEMI or NSTEMI) ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction, symptoms onset≤ 24h.NSTEMI was defined as elevated troponin levels and the absence of ST elevation at the time of diagnosis, PCI was performed within 24hours after symtoms onset.
- Sufficient quality of the OCT recording allowing for CoreLab analysis.
Key exclusion criteria (7 listed)
- ostial of Left main disease
- Cardiogenic shock or severe hemodynamic instability
- Severe renal insufficiency (creatinine clearance ≤30 mL/min)
- Bacteraemia or septicaemia
- Severe coagulation disorders
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 |
|---|---|---|
| OCT guided coronary interventionpatients were divided into two groups,on OCT guided coronary group and coronary angiography guided group | Device | OCT guided group, angiography guided group |
Primary outcome
major adverse cardiovascular event
Time frame: 3 year
including cardiovascualr death, myocardial infarction, and target lesion revascularization, target vessel revascularization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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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?
An observational study of Acute Myocardial Infarction, run by Beijing Luhe Hospital 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 3 inclusion and 7 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 4 Mar 2022. 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 Jincheng Guo, M.D. (8610-13521968844, guojcmd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular event (time frame: 3 year). 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 4 Mar 2022.