Myocardial InfarctionFu-AMINCT07405788
Percutaneous Coronary Intervention for Myocardial Infarction at Fujian Provincial Hospital
A study testing Percutaneous Coronary Intervention in people with Myocardial Infarction, run by Kaiyang Lin.
Trial summary
Research Objectives: This clinical trial aims to evaluate the efficacy and safety of percutaneous coronary intervention (PCI) in patients with myocardial infarction (MI). The primary objective is to determine whether this approach can reduce the incidence of major adverse cardiovascular events (MACE) compared to… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,344 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Inclusion Criteria:
- Clinical diagnosis of acute myocardial infarction.
- Successful direct or emergency PCI of the infarct-related artery.
- Ability to undergo randomization post-PCI.
- Ability to understand and voluntarily sign the informed consent form.
- Exclusion Criteria:
- PCI failure (final TIMI flow < grade 2) or presence of untreated severe stenosis.
- Planned staged PCI or other cardiac surgery within 3 months.
- Cardiogenic shock (Killip class IV), severe structural heart disease, or contraindications to PCI trial intervention.
- Active bleeding or high bleeding risk.
- Known allergy to the trial drug or its components.
- ALT/AST > 3x upper limit of normal (ULN); eGFR < 30 mL/min/1.73 m².
- Non-cardiovascular disease with life expectancy < 1 year (e.g., active malignancy).
- History of hemorrhagic stroke, or any ischemic stroke/transient ischemic attack within the past 6 months.
- Requirement for long-term oral anticoagulation therapy.
- Pregnancy, lactation, or women of childbearing potential not using effective contraception.
- Current participation in another interventional clinical trial.
- Any condition that may affect trial compliance, safety assessment, or result interpretation per investigator judgment.
About this study
Official title: A Registration Study on Percutaneous Coronary Intervention for Patients With Myocardial Infarction at Fujian Provincial Hospital
Research Objectives:
This clinical trial aims to evaluate the efficacy and safety of percutaneous coronary intervention (PCI) in patients with myocardial infarction (MI). The primary objective is to determine whether this approach can reduce the incidence of major adverse cardiovascular events (MACE) compared to current conservative treatment.
Read more
Research Questions:
This study aims to address the following key questions:
Does standard PCI improve the clinical outcomes of MI patients (such as cardiovascular death, recurrent myocardial infarction, or revascularization due to ischemia-driven vascular reconstruction)? How safe is PCI, especially in terms of bleeding risk, surgical-related complications, or other adverse events? Does PCI have a significant impact on specific secondary endpoints (such as stent thrombosis, hospitalization for heart failure, or quality of life indicators)?
- Conditions
- Myocardial Infarction
- Being tested
- Percutaneous Coronary Intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
The culprit vessels for this surgery: LAD, LCX, RCA, LM Number of stents implanted Total number of diseased vessels Postoperative medication use Preoperative TIMI grade of the culprit vessels, postoperative TIMI grade of the culprit vessels TIMI thrombus burden classification High thrombus burden Thrombus size Thrombus aspiration No reflow/slow blood flow Imaging assessment: baseline ejection fraction, left ventricular end-diastolic diameter, left ventricular end-systolic diameter EF values at follow-up, left ventricular end-diastolic diameter, left ventricular end-systolic diameter at follow-up Follow-up dates for cardiac ultrasound Follow-up dates for cardiac magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Experimental | The main indicators for evaluating the effectiveness and safety of the experimental intervention measures. Participants will receive the new or experimental treatment as stipulated in the trial protocol.
Intervention measures description: Standard percutaneous coronary intervention (PCI) Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants experiencing related adverse events after percutaneous coronary intervention
Baseline data: Age, gender, height, weight, body mass index, systolic blood pressure at admission, diastolic blood pressure at admission, heart rate, smoking history, past medical history Hospital Admission Situation Perioperative period: The diseased blood vessels, number of stent implants, and biochemical indicators of this surgery; Primary outcome indicators: During hospitalization, the number of related adverse events that occurred in patients around the 7th day after surgery - hematoma at the puncture site, contrast-induced nephropathy, coronary artery dissection, stent thrombosis, etc.
Hospitalization events: GRACE score, death during hospitalization Continuous follow-up until the last patient was enrolled (from June 2, 2017 to October 23, 2024): All-cause death, MACE1, stroke, recurrent myocardial infarction, stent restenosis, percutaneous coronary intervention, unplanned vascular reconstruction
Measured: From the time of enrollment (baseline) to the 7-year follow-up after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jan 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiyang Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kaiyang Lin, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405788
- Sponsor's protocol ID
- k2017-01-012
- Other IDs
- k2017-01-012
- Acronym
- Fu-AMI
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registration Study on Percutaneous Coronary Intervention for Patients With Myocardial Infarction at Fujian Provincial Hospital
- ClinicalTrials.gov ID
- NCT07405788
- Acronym / sponsor ID
- Fu-AMI / k2017-01-012
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,344 participants (actual)
- Lead sponsor
- Kaiyang LinUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Feb 2026 (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.
Research Objectives:
This clinical trial aims to evaluate the efficacy and safety of percutaneous coronary intervention (PCI) in patients with myocardial infarction (MI). The primary objective is to determine whether this approach can reduce the incidence of major adverse cardiovascular events (MACE) compared to current conservative treatment.
Research Questions:
This study aims to address the following key questions:
Does standard PCI improve the clinical outcomes of MI patients (such as cardiovascular death, recurrent myocardial infarction, or revascularization due to ischemia-driven vascular reconstruction)? How safe is PCI, especially in terms of bleeding risk, surgical-related complications, or other adverse events? Does PCI have a significant impact on specific secondary endpoints (such as stent thrombosis, hospitalization for heart failure, or quality of life indicators)?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Experimental | Procedure: Percutaneous Coronary InterventionThe main indicators for evaluating the effectiveness and safety of the experimental intervention measures. Participants will receive the new or experimental treatment as stipulated in the trial protocol. Intervention measures description: Standard percutaneous coronary intervention (PCI) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Percutaneous Coronary InterventionThe culprit vessels for this surgery: LAD, LCX, RCA, LM Number of stents implanted Total number of diseased vessels Postoperative medication use Preoperative TIMI grade of the culprit vessels, postoperative TIMI grade of the culprit vessels TIMI thrombus burden classification High thrombus burden Thrombus size Thrombus aspiration No reflow/slow blood flow Imaging assessment: baseline ejection fraction, left ventricular end-diastolic diameter, left ventricular end-systolic diameter EF values at follow-up, left ventricular end-diastolic diameter, left ventricular end-systolic diameter at follow-up Follow-up dates for cardiac ultrasound Follow-up dates for cardiac magnetic resonance imaging | Procedure or surgery | Percutaneous Coronary Intervention (PCI) |
Primary outcome
The number of participants experiencing related adverse events after percutaneous coronary intervention
Time frame: From the time of enrollment (baseline) to the 7-year follow-up after the surgery
Baseline data: Age, gender, height, weight, body mass index, systolic blood pressure at admission, diastolic blood pressure at admission, heart rate, smoking history, past medical history Hospital Admission Situation Perioperative period: The diseased blood vessels, number of stent implants, and biochemical indicators of this surgery; Primary outcome indicators: During hospitalization, the number of related adverse events that occurred in patients around the 7th day after surgery - hematoma at the puncture site, contrast-induced nephropathy, coronary artery dissection, stent thrombosis, etc. Hospitalization events: GRACE score, death during hospitalization Continuous follow-up until the last patient was enrolled (from June 2, 2017 to October 23, 2024): All-cause death, MACE1, stroke, recurrent myocardial infarction, stent restenosis, percutaneous coronary intervention, unplanned vascular reconstruction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- 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.
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 Percutaneous Coronary Intervention in people with Myocardial Infarction, run by Kaiyang Lin.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The number of participants experiencing related adverse events after percutaneous coronary intervention (time frame: From the time of enrollment (baseline) to the 7-year follow-up after the 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 12 Feb 2026.