STEMINCT05043597
Effectiveness Evaluation in Thrombus Aspiration in Patients With STEMI and High Thrombotic Load
A study testing Thrombus aspiration in people with STEMI, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
This study intends to evaluate thrombus on the basis of different methods for evaluating thrombus load The effect of aspiration on the prognosis of STEMI patients with high thrombotic load Provide a basis for the standardized use of aspiration; at the same time, discover the best benefit groups for thrombus aspiration Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- STEMI
- What is being tested?
- Thrombus aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,838 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 28 Feb 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age ≥ 18 years; (2) Voluntary signing of informed consent; (3) Onset of 12 hours STEMI patients who underwent PCI reperfusion therapy within time; (4) The guidewire passes through the lesion and the blood Heavy embolism load (TIMI thrombus classification ≥ 3).
Who cannot join
- (1) Hemodynamics is unstable or there is cardiogenic shock; (2) After thrombolytic therapy; (3) The expected survival time is less than 6 months due to non-cardiac diseases; (4) Past trips Coronary artery bypass graft patients; (5) Participate in other drug and device research within 30 days; (6) Before surgery, clear active gastrointestinal bleeding or other contraindications for taking dual antiplatelet drugs (7) Patients deemed unsuitable for enrollment by other researchers
Trial locations and contacts
1 site in 1 country.
About this study
This study intends to evaluate thrombus on the basis of different methods for evaluating thrombus load The effect of aspiration on the prognosis of STEMI patients with high thrombotic load Provide a basis for the standardized use of aspiration; at the same time, discover the best benefit groups for thrombus aspiration
- Conditions
- STEMI
- Being tested
- Thrombus aspiration
- 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.
Thrombus aspirationProcedure or surgery
Thrombus aspiration
| Study group | Role | What they receive |
|---|---|---|
| Thrombus aspiration | Experimental | Not described Receives: Procedure: Thrombus aspiration |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse cardiovascular events
Including cardiogenic death, recurring myocardial infarction Stent thrombosis or target vessel revascularization
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Mar 2020
- Primary completion1 Jan 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,838 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043597
- Sponsor's protocol ID
- LHD Thrombus aspiration
- Status last verified
- Sep 2021
- First submitted
- 25 Aug 2021
- Last updated
- 14 Sep 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 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Evaluation in Thrombus Aspiration in Patients With STEMI and High Thrombotic Load
- ClinicalTrials.gov ID
- NCT05043597
- Acronym / sponsor ID
- LHD Thrombus aspiration
- Conditions
- STEMI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,838 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 14 Sep 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 intends to evaluate thrombus on the basis of different methods for evaluating thrombus load The effect of aspiration on the prognosis of STEMI patients with high thrombotic load Provide a basis for the standardized use of aspiration; at the same time, discover the best benefit groups for thrombus aspiration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombus aspiration | Experimental | Procedure: Thrombus aspiration |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Age ≥ 18 years; (2) Voluntary signing of informed consent; (3) Onset of 12 hours STEMI patients who underwent PCI reperfusion therapy within time; (4) The guidewire passes through the lesion and the blood Heavy embolism load (TIMI thrombus classification ≥ 3).
Key exclusion criteria (1 listed)
- (1) Hemodynamics is unstable or there is cardiogenic shock; (2) After thrombolytic therapy; (3) The expected survival time is less than 6 months due to non-cardiac diseases; (4) Past trips Coronary artery bypass graft patients; (5) Participate in other drug and device research within 30 days; (6) Before surgery, clear active gastrointestinal bleeding or other contraindications for taking dual antiplatelet drugs (7) Patients deemed unsuitable for enrollment by other researchers
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 |
|---|---|---|
| Thrombus aspirationThrombus aspiration | Procedure or surgery | Thrombus aspiration |
Primary outcome
Adverse cardiovascular events
Time frame: 3 years
Including cardiogenic death, recurring myocardial infarction Stent thrombosis or 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 14 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombus aspiration in people with STEMI, run by Shenzhen People's 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 1 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 14 Sep 2021. 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?
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?
Adverse cardiovascular events (time frame: 3 years). 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 14 Sep 2021.