Efficacy of Thrombus Aspiration in Patients With Acute ST-Segment Elevation Myocardial Infarction… (NCT07551700) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Thrombus Aspiration in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized, Controlled, Single-Blind Clinical Trial
6,760 participantsStarted 2026-04-01
Plain-language summary
The goal of this clinical trial is to learn if adding standardized manual thrombus aspiration to primary percutaneous coronary intervention (PPCI) works better to improve heart health outcomes and protect long-term heart function in adults with acute ST-segment elevation myocardial infarction (STEMI) and a high blood clot burden in the heart's arteries. The main questions it aims to answer are:
* Does PPCI plus manual thrombus aspiration lower the risk of serious heart problems one year after treatment, compared to PPCI alone?
* Can manual thrombus aspiration better protect long-term heart function in people with a high blood clot burden? Researchers will compare two groups of participants-one group getting PPCI plus manual thrombus aspiration and one group getting only PPCI-to see if the aspiration treatment leads to fewer serious heart problems, better long-term heart function, and similar safety (including no higher risk of stroke).
Participants will:
* Have a heart artery scan (coronary angiography) to confirm a high blood clot burden
* Be randomly assigned to one of the two treatment groups for their PPCI procedure
* Complete follow-up checks at 30 days, 6 months, and 1 year after treatment, including heart function tests (like echocardiograms)
* Have heart magnetic resonance (CMR) scans if selected, to measure heart tissue damage and heart function
* Have their heart health status and any adverse events recorded throughout the study
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged ≥18 years old, diagnosed with acute ST-segment elevation myocardial infarction (STEMI) (chest pain plus ST-segment elevation ≥1mm or new-onset left bundle branch block \[LBBB\]) with symptom onset \< 12 hours.
* Planned to undergo primary percutaneous coronary intervention (PPCI).
* High thrombus burden in the target vessel (TIMI thrombus grade ≥3, or visible floating thrombus) confirmed by coronary angiography.
* Reference diameter of the target vessel ≥2.75mm, with the lesion suitable for the passage of an aspiration catheter.
* Provided written informed consent to participate in the study.
Exclusion Criteria:
* Cardiogenic shock (Killip class IV) or requiring mechanical circulatory support.
* A history of previous coronary artery bypass grafting (CABG).
* Concurrent intervention required for non-culprit vessels.
* Severe bleeding tendency (e.g., INR \> 2.5, platelet count \< 50×10⁹/L).
* Severe renal insufficiency (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²).
* Expected survival time \< 1 year (e.g., advanced malignant tumor).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing thrombus aspiration during heart attack treatment — can you explain what that procedure actually involves and how it differs from what I would receive in standard stent placement alone?
2The trial is measuring major adverse cardiovascular events over a full year after the procedure — does that mean the benefit or risk of thrombus aspiration may not be clear until well after my heart attack is treated, and how does that uncertainty affect my decision now?
3Since this trial is listed as 'not yet recruiting,' it isn't enrolling patients right now — given my situation, is waiting to potentially join this study realistic, or would starting standard treatment immediately be the safer path?
4This trial is listed as Phase N/A, which is sometimes used for procedure-based studies rather than drug trials — can you help me understand what that means for how much is already known about the safety and effectiveness of thrombus aspiration in STEMI patients like me?
5Are there already published results from similar thrombus aspiration trials that you would use to guide my treatment today, and how would joining this randomized study differ from simply receiving the treatment based on your clinical judgment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite major adverse cardiovascular events (MACEs) at 1 year after the procedure
Timeframe: 1 year post-procedure
Trial details
NCT IDNCT07551700
SponsorFirst Affiliated Hospital Xi'an Jiaotong University