ST Elevation Myocardial InfarctionNCT04996277
A Prospective Evaluation of Clinical Impact of Physiology Versus Optical Coherence Tomography Guided PCI in STEMI Patients Without Undergoing Primary PCI
A study testing angiography, Thrombus suction and Fibrinolytic therapy in people with ST Elevation Myocardial Infarction, run by CCRF Inc., Beijing, China.
Trial summary
This study of physiologically functional FFR in STEMI patients without direct PCI treatment will provide unique data on plaque progression and risk factors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- angiography, Thrombus suction and Fibrinolytic therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2021to 1 Mar 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≤ 18 ≤75;
- 7-30 days after onset of STEMI;
- PCI was not performed for the following reasons:
- Stabilize the condition at a hospital that is unable to provide PCI and then refer to a tertiary hospital for further evaluation;
- Previous emergency angiography without balloon dilatation or stent implantation; Emergency thrombus aspiration without balloon dilation or stent placement;
- Patients with target lesion stenosis of 50%-90%, GRADE 3 TIMI blood flow and indications for stent implantation after receiving STEMI treatment in accordance with hospital standard procedures.
Who cannot join
- Left main disease or bypass disease;
- Intolerance to research drugs, metal alloys or contrast agents;
- Life expectancy is less than a year;
- PCI was performed on previous target vessels;
- Previous coronary artery bypass grafting;
- cardiogenic shock or LVEF\< 35%;
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- Severe renal or liver dysfunction;
- Hemodynamic instability;
- The degree of pathological stenosis of criminals was > 90% or < 50%;
- Target vessel TIMI blood flow ≤ grade 2;
- A surgical plan within 6 months after the initial operation;
- Had clinical indications of intolerance to 12-month DAPT therapy;
- Unable to provide written proof of informed consent;
- Patients who were enrolled in other clinical trials at the time of enrollment and did not meet the primary study endpoint.
About this study
This study of physiologically functional FFR in STEMI patients without direct PCI treatment will provide unique data on plaque progression and risk factors.
Read the detailed description
This is a prospective, randomized, controlled, multicenter clinical study that plans to continuously enroll patients with STEMI who, for various reasons, have not received direct PCI treatment within 48 hours of symptom onset. All STEMI patients will be treated according to the hospital's standard procedures and will continue to watch for plaque stability for 7 to 30 days. Treatment options for STEMI include: progressive thrombus aspiration without balloon or stent implantation; Stabilization with medication in a relatively small hospital that could not provide PCI treatment and then transfer to a tertiary hospital for further evaluation; Thrombolytic therapy. After that, all patients underwent an angiogram to identify any residual stenosis in the culprit's blood vessels.
In this study, 300 subjects with target vessel stenosis of 50%-90% confirmed to be suitable for stent implantation by angiographic evaluation will be recruited and randomly assigned to FFR, OCT or Angio group according to 1:1:1. FFR group: Patients with FFR ≤0.8 were treated with PCI; FFR \> 0.8 patients will receive drug therapy; All patients will undergo OCT examination. OCT group: if MLA\< 4.5mm2 patients will receive PCI; Other patients will be treated with medication; All patients will be examined for FFR. Angio group: The appropriate treatment (stent implantation) will be given according to the evaluation of the doctor.
All patients were followed up at 1 month (±7d), 6 months (±14d) and 12 months (±30d) after surgery, respectively. Target lesion failure (TLF), including cardiogenic death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (TLR), was used as the primary end point. Secondary end points included the incidence of major adverse cardiovascular events (MACE) at 1 year postoperatively. The clinical composite end points included: All due to death, Arc-defined stent thrombotic events, non-fatal myocardial infarction, clinically driven target vessel revascularization, or readmission due to unstable angina pectoris or aggravation of angina; Patients in the FFR group and OCT group were treated with a change of treatment strategy (pre-PCI: change of stent implantation strategy; After PCI: with or without additional intervention).
Each research center shall operate and test in accordance with the operating procedures uniformly described in the scheme to ensure the consistency of the test operation.
Clinical event committee (CEC) : a clinical event committee will be composed of independent cardiologists not involved in this study to reevaluate all reported deaths, myocardial infarction, revascularization, and thrombotic events.
A total of 300 STEMI patients who did not receive direct PCI treatment within 48 hours after symptom onset due to different reasons are planned to be enrolled in 16 centers nationwide. The overall study time is about 24 months.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- angiography, Thrombus suction, Fibrinolytic therapy, Medication stabilized the condition
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angiographyProcedure or surgery
All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.
Thrombus suctionProcedure or surgery
All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.
Fibrinolytic therapyProcedure or surgery
All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.
Medication stabilized the conditionBehavioural
All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Fractional Flow Reserve | Experimental | Patients with FFR ≤ 0.8 will undergo PCI Patients with FFR > 0.8 will be treated with medication For study purposes, all patients will undergo OCT (subject's treatment strategy will be based on FFR results, e.g., stent-implanted OCT). Receives: Procedure: angiography; Procedure: Thrombus suction; Procedure: Fibrinolytic therapy; Behavioral: Medication stabilized the condition |
| Optical CoherenceTomography | Experimental | Patients with MLA < 4.5mm² will undergo PCI Other patients will be treated with medication For study purposes, all patients will undergo FFR (subject's treatment strategy is based on OCT results; reference to FFR results is not recommended) Receives: Procedure: angiography; Procedure: Thrombus suction; Procedure: Fibrinolytic therapy; Behavioral: Medication stabilized the condition |
| angiography | Experimental | Appropriate treatment (implantation of stents) will be given according to the evaluation of the physician. Receives: Procedure: angiography; Procedure: Thrombus suction; Procedure: Fibrinolytic therapy; Behavioral: Medication stabilized the condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
These include cardiogenic death, target vascular-associated myocardial infarction, and ischaemic driven revascularization of target lesions
Measured: 1 year after baseline surgery
Secondary outcomes (2)
Major Adverse Cardiovascular Events
All-cause death; ARC defined stent thrombosis events; This is a nonfatal myocardial infarction Anyway, a clinically-driven revascularization of a target blood vessel or hospital re-admission due to unstable angina or worsening angina
Measured: 1 year after baseline surgery
Incidence of changes in treatment strategy in FFR and OCT patients
Change of stent implantation strategy before PCI and additional intervention or no additional intervention after PCI
Measured: 1 year after baseline surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start31 Jul 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, 300 subjects with target vessel stenosis of 50%-90% confirmed to be suitable for stent implantation by angiographic evaluation will be recruited and randomly assigned to FFR, OCT or Angio group according to 1:1:1. FFR group: Patients with FFR ≤0.8 were treated with PCI; FFR \> 0.8 patients will receive drug therapy; All patients will undergo OCT examination. OCT group: if MLA\< 4.5mm2 patients will receive PCI; Other patients will be treated with medication; All patients will be examined for FFR. Angio group: The appropriate treatment (stent implantation) will be given according to the evaluation of the doctor.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCRF Inc., Beijing, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Yaling Han, M.d., Ph.D., General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996277
- Sponsor's protocol ID
- OCT-STEMI-2020
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2021
- Last updated
- 9 Aug 2021
- 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Clinical Impact of Physiology Versus Optical Coherence Tomography Guided PCI in STEMI Patients Without Undergoing Primary PCI
- ClinicalTrials.gov ID
- NCT04996277
- Acronym / sponsor ID
- OCT-STEMI-2020
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CCRF Inc., Beijing, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Study start
- 31 Jul 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 9 Aug 2021 (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 study of physiologically functional FFR in STEMI patients without direct PCI treatment will provide unique data on plaque progression and risk factors.
Detailed description
This is a prospective, randomized, controlled, multicenter clinical study that plans to continuously enroll patients with STEMI who, for various reasons, have not received direct PCI treatment within 48 hours of symptom onset. All STEMI patients will be treated according to the hospital's standard procedures and will continue to watch for plaque stability for 7 to 30 days. Treatment options for STEMI include: progressive thrombus aspiration without balloon or stent implantation; Stabilization with medication in a relatively small hospital that could not provide PCI treatment and then transfer to a tertiary hospital for further evaluation; Thrombolytic therapy. After that, all patients underwent an angiogram to identify any residual stenosis in the culprit's blood vessels.
In this study, 300 subjects with target vessel stenosis of 50%-90% confirmed to be suitable for stent implantation by angiographic evaluation will be recruited and randomly assigned to FFR, OCT or Angio group according to 1:1:1. FFR group: Patients with FFR ≤0.8 were treated with PCI; FFR \> 0.8 patients will receive drug therapy; All patients will undergo OCT examination. OCT group: if MLA\< 4.5mm2 patients will receive PCI; Other patients will be treated with medication; All patients will be examined for FFR. Angio group: The appropriate treatment (stent implantation) will be given according to the evaluation of the doctor.
All patients were followed up at 1 month (±7d), 6 months (±14d) and 12 months (±30d) after surgery, respectively. Target lesion failure (TLF), including cardiogenic death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (TLR), was used as the primary end point. Secondary end points included the incidence of major adverse cardiovascular events (MACE) at 1 year postoperatively. The clinical composite end points included: All due to death, Arc-defined stent thrombotic events, non-fatal myocardial infarction, clinically driven target vessel revascularization, or readmission due to unstable angina pectoris or aggravation of angina; Patients in the FFR group and OCT group were treated with a change of treatment strategy (pre-PCI: change of stent implantation strategy; After PCI: with or without additional intervention).
Each research center shall operate and test in accordance with the operating procedures uniformly described in the scheme to ensure the consistency of the test operation.
Clinical event committee (CEC) : a clinical event committee will be composed of independent cardiologists not involved in this study to reevaluate all reported deaths, myocardial infarction, revascularization, and thrombotic events.
A total of 300 STEMI patients who did not receive direct PCI treatment within 48 hours after symptom onset due to different reasons are planned to be enrolled in 16 centers nationwide. The overall study time is about 24 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In this study, 300 subjects with target vessel stenosis of 50%-90% confirmed to be suitable for stent implantation by angiographic evaluation will be recruited and randomly assigned to FFR, OCT or Angio group according to 1:1:1. FFR group: Patients with FFR ≤0.8 were treated with PCI; FFR \> 0.8 patients will receive drug therapy; All patients will undergo OCT examination. OCT group: if MLA\< 4.5mm2 patients will receive PCI; Other patients will be treated with medication; All patients will be examined for FFR. Angio group: The appropriate treatment (stent implantation) will be given according to the evaluation of the doctor.
| Arm | Type | Receives |
|---|---|---|
| Fractional Flow Reserve | Experimental | Procedure: angiography, Procedure: Thrombus suction, Procedure: Fibrinolytic therapy, Behavioral: Medication stabilized the conditionPatients with FFR ≤ 0.8 will undergo PCI Patients with FFR > 0.8 will be treated with medication For study purposes, all patients will undergo OCT (subject's treatment strategy will be based on FFR results, e.g., stent-implanted OCT). |
| Optical CoherenceTomography | Experimental | Procedure: angiography, Procedure: Thrombus suction, Procedure: Fibrinolytic therapy, Behavioral: Medication stabilized the conditionPatients with MLA < 4.5mm² will undergo PCI Other patients will be treated with medication For study purposes, all patients will undergo FFR (subject's treatment strategy is based on OCT results; reference to FFR results is not recommended) |
| angiography | Experimental | Procedure: angiography, Procedure: Thrombus suction, Procedure: Fibrinolytic therapy, Behavioral: Medication stabilized the conditionAppropriate treatment (implantation of stents) will be given according to the evaluation of the physician. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≤ 18 ≤75;
- 7-30 days after onset of STEMI;
- PCI was not performed for the following reasons:
- Patients with target lesion stenosis of 50%-90%, GRADE 3 TIMI blood flow and indications for stent implantation after receiving STEMI treatment in accordance with hospital standard procedures.
Key exclusion criteria (14 listed)
- Left main disease or bypass disease;
- Intolerance to research drugs, metal alloys or contrast agents;
- Life expectancy is less than a year;
- PCI was performed on previous target vessels;
- Previous coronary artery bypass grafting;
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 |
|---|---|---|
| angiographyAll STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy. | Procedure or surgery | Fractional Flow Reserve, Optical CoherenceTomography, angiography |
| Thrombus suctionAll STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy. | Procedure or surgery | Fractional Flow Reserve, Optical CoherenceTomography, angiography |
| Fibrinolytic therapyAll STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy. | Procedure or surgery | Fractional Flow Reserve, Optical CoherenceTomography, angiography |
| Medication stabilized the conditionAll STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy. | Behavioural | Fractional Flow Reserve, Optical CoherenceTomography, angiography |
Primary outcome
Target lesion failure
Time frame: 1 year after baseline surgery
These include cardiogenic death, target vascular-associated myocardial infarction, and ischaemic driven revascularization of target lesions
2 secondary outcomes
Major Adverse Cardiovascular Events
Time frame: 1 year after baseline surgery
Incidence of changes in treatment strategy in FFR and OCT patients
Time frame: 1 year after baseline surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing angiography, Thrombus suction and Fibrinolytic therapy in people with ST Elevation Myocardial Infarction, run by CCRF Inc., Beijing, 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 6 inclusion and 14 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 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 1 year after baseline surgery). 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 9 Aug 2021.