Acute ST Elevation Myocardial InfarctionINVEST-MINCT01878487
Assessment of Lumen Expansion After Thrombus Extraction in Primary Percutaneous Coronary Intervention
A study testing Thrombus aspiration (Intravascular Ultrasound catheter (Boston)) in people with Acute ST Elevation Myocardial Infarction, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter in 40 patients during primary PCI. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute ST Elevation Myocardial Infarction
- What is being tested?
- Thrombus aspiration (Intravascular Ultrasound catheter (Boston))
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to May 2013
- 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
- patients 18-75 years old with myocardial infarction with ST-segment elevation
- symptoms of myocardial ischemia lasting more than 30 minutes
- onset of symptoms within 12 hours of hospital presentation
- ST-segment elevation of more than 0.1 mV in two or more leads on the ECG
Who cannot join
- inability to obtain informed consent
- use of fibrinolytic drug within 12 hours of presentation
- comorbidity with anticipated life expectancy of < 6 months
- cardiogenic shock on presentation
- major bleeding diathesis
- history of aspirin and clopidogrel intolerance
Show all 10Show fewer
- critical left main stem lesions
- severe calcfic disease precluding safe passage of the imaging catheter
- culprit lesion within saphenous vein grafts
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Cardiology, Freeman Hospital
Newcastle
About this study
Official title: INtra-Vascular Ultrasound Study of Export Thrombectomy in ST Elevation Myocardial Infarction Myocardial Infarction
To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter in 40 patients during primary PCI.
Read the detailed description
Primary PCI has become the preferred therapy for ST-elevation acute myocardial infarction. The TAPAS trial data suggests that widespread adoption of manual thrombus aspiration may improve clinical outcomes for patients undergoing primary PCI.
Little data exists on the degree to which thrombus is removed during thrombectomy and how much thrombus remains with the potential for distal embolisation during stent deployment. The mechanism of lumen enlargement after thrombus aspiration is also unknown. Since angiography only provides an outline image of the vascular lumen, such questions cannot be adequately addressed by this modality alone.
The aim of this study is to use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter during primary PCI.
Hypotheses In this study we will assess 40 patients with STEMI. Primary PCI will be performed according to our hospital standard working protocol with thrombus aspiration and balloon dilatation of the culprit lesion if necessary prior to stent deployment. IVUS imaging will be undertaken prior to, and following, passage of the aspirations catheter to assess (1) initial and (2) residual thrombus volume. A third and final IVUS imaging run will be performed after stenting of the culprit lesion. IVUS analysis will be performed off-line to assess the lumen enlargement and volume of residual thrombus at each stage. All studies will be undertaken with the approval of the local Clinical Research Ethics.
Aspirated material will be collected and analyzed. Clinical markers such as Troponin release and left ventricular function will be assessed.
- Conditions
- Acute ST Elevation Myocardial Infarction
- Being tested
- Thrombus aspiration (Intravascular Ultrasound catheter (Boston))
- Keywords
- Acute MI, Primary percutaneous coronary intervention, thrombus aspiration, IVUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombus aspiration (Intravascular Ultrasound catheter (Boston))Device
Also called Export thrombus aspiration cathether, Intravascular Ultrasound catheter (Boston)
There is a single arm in the study where all patients are undergoing primary percutaneous coronary intervention for an acute myocardial infarction.
All patients will have an Intravascular Ultrasound three times:
- At baseline
- After thrombus aspiration with a thrombus extraction catheter
- After stent deployment
We are however assessing the physiological response of patients having an acute myocardial infarction and this is not a test of the devices as such.
| Study group | Role | What they receive |
|---|---|---|
| Only one arm | Other | All patients will receive the same treatment, i.e. there is no randomization. There is therefore only one arm, all patients will by treated as per standard practice with thrombus aspiration and stenting as required, the lumen size of the vessel will be assessed with intravascular ultrasound at baseline, after thrombus aspiration and after stenting. Receives: Device: Thrombus aspiration (Intravascular Ultrasound catheter (Boston)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery lumen expansion after thrombus aspiration in primary percutaneous intervention.
Degree of thrombus extraction can be visualised immediately by intravascular ultrasound (IVUS) but detailed analysis will be carried out off-line and by histopathology of aspirated material within 4 months.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878487
- Sponsor's protocol ID
- 09/H0906/85
- Acronym
- INVEST-MI
- Status last verified
- Oct 2015
- First submitted
- 1 May 2013
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtra-Vascular Ultrasound Study of Export Thrombectomy in ST Elevation Myocardial Infarction Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01878487
- Acronym / sponsor ID
- INVEST-MI / 09/H0906/85
- Conditions
- Acute ST Elevation Myocardial Infarction
- Keywords
- Acute MI, Primary percutaneous coronary intervention, thrombus aspiration, IVUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 Jun 2013 (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.
To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter in 40 patients during primary PCI.
Detailed description
Primary PCI has become the preferred therapy for ST-elevation acute myocardial infarction. The TAPAS trial data suggests that widespread adoption of manual thrombus aspiration may improve clinical outcomes for patients undergoing primary PCI.
Little data exists on the degree to which thrombus is removed during thrombectomy and how much thrombus remains with the potential for distal embolisation during stent deployment. The mechanism of lumen enlargement after thrombus aspiration is also unknown. Since angiography only provides an outline image of the vascular lumen, such questions cannot be adequately addressed by this modality alone.
The aim of this study is to use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter during primary PCI.
Hypotheses In this study we will assess 40 patients with STEMI. Primary PCI will be performed according to our hospital standard working protocol with thrombus aspiration and balloon dilatation of the culprit lesion if necessary prior to stent deployment. IVUS imaging will be undertaken prior to, and following, passage of the aspirations catheter to assess (1) initial and (2) residual thrombus volume. A third and final IVUS imaging run will be performed after stenting of the culprit lesion. IVUS analysis will be performed off-line to assess the lumen enlargement and volume of residual thrombus at each stage. All studies will be undertaken with the approval of the local Clinical Research Ethics.
Aspirated material will be collected and analyzed. Clinical markers such as Troponin release and left ventricular function will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only one arm | Other | Device: Thrombus aspiration (Intravascular Ultrasound catheter (Boston))All patients will receive the same treatment, i.e. there is no randomization. There is therefore only one arm, all patients will by treated as per standard practice with thrombus aspiration and stenting as required, the lumen size of the vessel will be assessed with intravascular ultrasound at baseline, after thrombus aspiration and after stenting. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients 18-75 years old with myocardial infarction with ST-segment elevation
- symptoms of myocardial ischemia lasting more than 30 minutes
- onset of symptoms within 12 hours of hospital presentation
- ST-segment elevation of more than 0.1 mV in two or more leads on the ECG
Key exclusion criteria (10 listed)
- inability to obtain informed consent
- use of fibrinolytic drug within 12 hours of presentation
- comorbidity with anticipated life expectancy of < 6 months
- cardiogenic shock on presentation
- major bleeding diathesis
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 aspiration (Intravascular Ultrasound catheter (Boston))Also: Export thrombus aspiration cathether, Intravascular Ultrasound catheter (Boston)There is a single arm in the study where all patients are undergoing primary percutaneous coronary intervention for an acute myocardial infarction. All patients will have an Intravascular Ultrasound three times: 1. At baseline 2. After thrombus aspiration with a thrombus extraction catheter 3. After stent deployment We are however assessing the physiological response of patients having an acute myocardial infarction and this is not a test of the devices as such. | Device | Only one arm |
Primary outcome
Coronary artery lumen expansion after thrombus aspiration in primary percutaneous intervention.
Time frame: Day 1
Degree of thrombus extraction can be visualised immediately by intravascular ultrasound (IVUS) but detailed analysis will be carried out off-line and by histopathology of aspirated material within 4 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 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.
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 (Intravascular Ultrasound catheter (Boston)) in people with Acute ST Elevation Myocardial Infarction, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 12 Oct 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coronary artery lumen expansion after thrombus aspiration in primary percutaneous intervention. (time frame: Day 1). 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 Oct 2015.