AngioplastyNCT00370578
Aspiration Device in Myocardial Infarction Trial
A study testing repeated thrombus aspiration during primary PCI in people with Angioplasty, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI). The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty
- What is being tested?
- repeated thrombus aspiration during primary PCI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Jun 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with STEMI<12 from synptoms onset
- eligble for primary PCI regardless of initial TIMI flow grade.
- patients for rescue PCI after failed thrombolysis will also be included
Who cannot join
- womwn with known pregnancy or who are lactating
- pts with allergy to aspirin, clopidogrel or heparin
- inability to obtain informed consent
- known existence of life threatening diseases with a life expectency less than 6 months
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
HaEmek Medical Center
Afula, 18101
Khalid Suleiman, MD, 972-46494017 ext. 4017, sulieman_k@clalit.org.il
Alexander Feldman, MD, 972-46495585, feldman_a@clalit.org.il
About this study
Official title: Aspiration Device Myocardial Infarction Trial
Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI).
The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI population.
Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique.
Read the detailed description
ADMIT-Randomized Single Center Study with two arms:
Standard PCI versus Primary PCI, using thrombus aspiration device after ever step of the procedure.
Issues to be examined are:
- Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae,
- Infarc size evaluated by serum markers and non invasive parameters
- In hospital major adverse cardiac events
- Major adverse cardiac events during 30\& 180 days of follow up
- Conditions
- Angioplasty
- Being tested
- repeated thrombus aspiration during primary PCI
- Keywords
- STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW
- Medical subject headings
- ST Elevation Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated thrombus aspiration during primary PCIDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Limitation of infarct size
Early and follow up related (MACE)-major adverse cardiac events
Secondary outcomes (1)
Efficacy of using aspiration device after every stage of Primary angiplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startSep 2006
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioplastyStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Yoav Turgeman, MD, Principal investigator, Technion-school of medicine, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370578
- Sponsor's protocol ID
- HaE064990ctil
- Other IDs
- Yoav Turgeman MD
- Status last verified
- Aug 2006
- First submitted
- 9 Aug 2006
- Last updated
- 28 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration Device Myocardial Infarction Trial
- ClinicalTrials.gov ID
- NCT00370578
- Acronym / sponsor ID
- HaE064990ctil
- Conditions
- Angioplasty
- Keywords
- STEMI, THROMBUS, ASPIRATION DEVICE, NO REFLOW
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Jun 2008 (estimated)
- First posted
- 31 Aug 2006 (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.
Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI).
The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI population.
Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique.
Detailed description
ADMIT-Randomized Single Center Study with two arms:
Standard PCI versus Primary PCI, using thrombus aspiration device after ever step of the procedure.
Issues to be examined are:
- Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae,
- Infarc size evaluated by serum markers and non invasive parameters
- In hospital major adverse cardiac events
- Major adverse cardiac events during 30\& 180 days of follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with STEMI<12 from synptoms onset
- eligble for primary PCI regardless of initial TIMI flow grade.
- patients for rescue PCI after failed thrombolysis will also be included
Key exclusion criteria (4 listed)
- womwn with known pregnancy or who are lactating
- pts with allergy to aspirin, clopidogrel or heparin
- inability to obtain informed consent
- known existence of life threatening diseases with a life expectency less than 6 months
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 |
|---|---|---|
| repeated thrombus aspiration during primary PCI | Device | – |
Primary outcome
Limitation of infarct size
Early and follow up related (MACE)-major adverse cardiac events
1 secondary outcome
Efficacy of using aspiration device after every stage of Primary angiplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2007.
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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.
Yoav Turgeman, MD principal investigator
Technion-school of medicine, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repeated thrombus aspiration during primary PCI in people with Angioplasty, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 3 inclusion and 4 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 28 Aug 2007. 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 Israel. 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?
Contact YOAV TURGEMAN, MD (972-46494016 ext. 5264, yoav_t@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limitation of infarct size. The study lists 2 primary outcomes in all. 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 28 Aug 2007.