ST-segment Elevation Myocardial InfarctionPhase 4NCT02606435
Thrombus Aspiration in Patients With STEMI
A Phase 4 study testing percutaneous coronary intervention (PCI) and thrombus aspiration in people with ST-segment Elevation Myocardial Infarction, run by Xijing Hospital at 1 site in China.
Trial summary
This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction
- What is being tested?
- percutaneous coronary intervention (PCI) and thrombus aspiration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Nov 2017
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-80;
- Diagnosed as STEMI for presenting symptoms or definite ECG and myocardial markers changes;
- Patients presenting with definite ECG changes indicating STEMI: ST elevation of 0.1 mV in 2 contiguous limb leads or ≥0.2 mV in 2 contiguous precordial leads;
- Referred for PCI for presenting symptoms, and the coronary angiogram (CAG) shows that the initial TIMI thrombus grade ≥2;
- Informed consent.
Who cannot join
- Previous history of myocardiopathy, valvular heart disease or severe heart failure;
- Severe hepatic or renal dysfunction;
- Life expectancy less than 1 year;
- Prior PCI or CABG;
- Contraindications of using anticoagulation or antiplatelet drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing hospital
Xi'an, Shaanxi, 710032
Dongdong Sun, M.D.,Ph.D, 86 18691569930, wintersun3@gmail.com
About this study
Official title: Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)
This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).
Read the detailed description
This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.
- Being tested
- percutaneous coronary intervention (PCI), 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.
percutaneous coronary intervention (PCI)Procedure or surgery
Also called primary percutaneous coronary intervention (PCI)
percutaneous coronary intervention (PCI) by stent implantation
thrombus aspirationDevice
Also called export catheter
thrombus aspiration with export catheter
| Study group | Role | What they receive |
|---|---|---|
| thrombus aspiration with PCI | Experimental | patient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI) Receives: Procedure: percutaneous coronary intervention (PCI); Device: thrombus aspiration |
| PCI alone | Active comparator | patients will receive percutaneous coronary intervention (PCI) alone including stent implantation Receives: Procedure: percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
number of participants with cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure
Measured: 1 year
Secondary outcomes (5)
Number of participants with stent thrombosis
number of participants with stent thrombosis
Measured: 1 year
Number of participants with target vessel revascularization
number of participants with target vessel revascularization
Measured: 1 year
left ventricular function
left ventricular ejection fraction evaluated by ultrasound
Measured: 1 year
Seattle Angina Questionnaire scores
Seattle Angina Questionnaire scores
Measured: 1 year
6-minute walk distance (6MWD)
6-minute walk distance (6MWD)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sunddong, Xijing Hospital
- Investigators
- Dongdong Sun, M.D.,Ph.D., Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606435
- Sponsor's protocol ID
- SEED
- Status last verified
- Nov 2015
- First submitted
- 11 Nov 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)
- ClinicalTrials.gov ID
- NCT02606435
- Acronym / sponsor ID
- SEED
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 17 Nov 2015 (estimated)
- 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 is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).
Detailed description
This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thrombus aspiration with PCI | Experimental | Procedure: percutaneous coronary intervention (PCI), Device: thrombus aspirationpatient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI) |
| PCI alone | Active comparator | Procedure: percutaneous coronary intervention (PCI)patients will receive percutaneous coronary intervention (PCI) alone including stent implantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18-80;
- Diagnosed as STEMI for presenting symptoms or definite ECG and myocardial markers changes;
- Patients presenting with definite ECG changes indicating STEMI: ST elevation of 0.1 mV in 2 contiguous limb leads or ≥0.2 mV in 2 contiguous precordial leads;
- Referred for PCI for presenting symptoms, and the coronary angiogram (CAG) shows that the initial TIMI thrombus grade ≥2;
- Informed consent.
Key exclusion criteria (5 listed)
- Previous history of myocardiopathy, valvular heart disease or severe heart failure;
- Severe hepatic or renal dysfunction;
- Life expectancy less than 1 year;
- Prior PCI or CABG;
- Contraindications of using anticoagulation or antiplatelet drugs.
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 intervention (PCI)Also: primary percutaneous coronary intervention (PCI)percutaneous coronary intervention (PCI) by stent implantation | Procedure or surgery | PCI alone, thrombus aspiration with PCI |
| thrombus aspirationAlso: export catheterthrombus aspiration with export catheter | Device | thrombus aspiration with PCI |
Primary outcome
Major adverse cardiac events
Time frame: 1 year
number of participants with cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure
5 secondary outcomes
Number of participants with stent thrombosis
Time frame: 1 year
Number of participants with target vessel revascularization
Time frame: 1 year
left ventricular function
Time frame: 1 year
Seattle Angina Questionnaire scores
Time frame: 1 year
6-minute walk distance (6MWD)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Dongdong Sun, M.D.,Ph.D. principal investigator
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing percutaneous coronary intervention (PCI) and thrombus aspiration in people with ST-segment Elevation Myocardial Infarction, run by Xijing 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 5 inclusion and 5 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 17 Nov 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dongdong Sun, M.D.,Ph.D. (86 29 84775183, wintersun3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 1 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 17 Nov 2015.