ThrombosisNCT01705665
Histopathology of the Aspirated Thrombus During Acute Myocardial Infarction
An observational study of Thrombosis and Acute Coronary Syndrome, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
This study was initiated on the preliminary premise that a thrombus whose formation was triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue factor initiated thrombus), may evolve differently than the one evolving at the site of a recently implanted stent (foreign body triggered). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Acute Coronary Syndrome
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- 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
Study population: Patients admitted for an acute coronary syndrome who undergo angiography, found to have a coronary thrombosis that is aspirated and which yields thrombus fragments.
Who may be able to join
- Patients with acute coronary syndrome who undergo angiography
- Evidence of coronary thrombus
- Undergo aspiration procedure yielding thrombus fragments
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Heart Institute, Hillel Yaffe Medical Center
Hadera, 38100
Simcha R Meisel, MD, MSc, 972-4-6304470, meisel@hy.health.gov.il
Simcha R Meisel, MD, MSc
About this study
This study was initiated on the preliminary premise that a thrombus whose formation was triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue factor initiated thrombus), may evolve differently than the one evolving at the site of a recently implanted stent (foreign body triggered). Consequently, the thrombus composition of a de novo clot could differ from the other one, extracted during the occurrence of a subacute thrombosis, regarding the number of various cells, the amount of fibrin and platelet aggregates and the relationship among these components. In addition, it seems relevant to evaluate the numbers and the distribution of the local monocytes, once these cells may interact with platelets (via cell -adhesion mechanisms e.g., by CD31 [PECAM-1]) and by the extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident macrophages). Such a distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary arteries, and may have clinical implications.
- Conditions
- Thrombosis, Acute Coronary Syndrome
- Medical subject headings
- Thrombosis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aspirated Coronary Thrombi During AMI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Possible Difference in Composition of Thrombi Aspirated during Acute Myocardial Infarction Precipitated by de novo vs Subacute Thrombosis
Analysis of thrombotic specimen contents aspirated during Acute Myocardial Infarction by searching for possible differences in the components of the thrombotic debris, whether cellular, or fibrin and platelets, in accordance with clinical parameters.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705665
- Sponsor's protocol ID
- HYMC-70-10
- Status last verified
- Oct 2012
- First submitted
- 10 Oct 2012
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathology of the Aspirated Thrombus During Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01705665
- Acronym / sponsor ID
- HYMC-70-10
- Conditions
- Thrombosis, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Oct 2012 (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 study was initiated on the preliminary premise that a thrombus whose formation was triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue factor initiated thrombus), may evolve differently than the one evolving at the site of a recently implanted stent (foreign body triggered). Consequently, the thrombus composition of a de novo clot could differ from the other one, extracted during the occurrence of a subacute thrombosis, regarding the number of various cells, the amount of fibrin and platelet aggregates and the relationship among these components. In addition, it seems relevant to evaluate the numbers and the distribution of the local monocytes, once these cells may interact with platelets (via cell -adhesion mechanisms e.g., by CD31 [PECAM-1]) and by the extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident macrophages). Such a distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary arteries, and may have clinical implications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspirated Coronary Thrombi During AMI | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for an acute coronary syndrome who undergo angiography, found to have a coronary thrombosis that is aspirated and which yields thrombus fragments.
Key inclusion criteria (3 listed)
- Patients with acute coronary syndrome who undergo angiography
- Evidence of coronary thrombus
- Undergo aspiration procedure yielding thrombus fragments
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of Possible Difference in Composition of Thrombi Aspirated during Acute Myocardial Infarction Precipitated by de novo vs Subacute Thrombosis
Time frame: two years
Analysis of thrombotic specimen contents aspirated during Acute Myocardial Infarction by searching for possible differences in the components of the thrombotic debris, whether cellular, or fibrin and platelets, in accordance with clinical parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis and Acute Coronary Syndrome, run by Hillel Yaffe Medical Center 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 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 23 Oct 2012. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Possible Difference in Composition of Thrombi Aspirated during Acute Myocardial Infarction Precipitated by de novo vs Subacute Thrombosis (time frame: two 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 23 Oct 2012.