Coagulation DisorderNCT03391622
Thrombin Generation Values and Percutaneous Coronary Intervention Results.
An observational study of Coagulation Disorder and Ischemic Heart Disease, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Cardiovascular diseases are the most common cause of death in the western world. Myocardial infarction pathogenesis usually involves the development of an atherosclerotic plaque and thrombus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation Disorder, Ischemic Heart Disease, Artery Coronary Stenosis
- What is being tested?
- Calibrated Automated Thrombogram
- Type of treatment
- Medical device
- How many people
- 128 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2018to 30 Aug 2020
- 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: adult with Acute coronary syndrome: ST segment elevation myocardial infraction, unstable angina, non ST elevation myocardial infraction or patients presented with chest pain suspect for acute coronary syndrome .
Who may be able to join
- Acute coronary syndrome: ST segment elevation myocardial infraction, unstable angina, non ST elevation myocardial infraction or patients presented with chest pain suspect for acute coronary syndrome .
- planned percutaneous coronary intervention.
- ability to give Informed consent.
Who cannot join
- Acute coronary syndrome in the last 6 month prior to current event.
- thrombophilia
- pregnancy
- liver failure or cirrhosis
- anticoagulant current use
- active cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Correlation Between Thrombin Generation Values and Percutaneous Coronary Intervention Results in Active Ischemic Heart Disease Patients.
Cardiovascular diseases are the most common cause of death in the western world. Myocardial infarction pathogenesis usually involves the development of an atherosclerotic plaque and thrombus.
Past research has shown a correlation between thrombin generation values and ischemic heart disease, however, to our knowledge no investigation has been done into the correlation of thrombin generation and cardiac catheterization results in ischemic heart disease patients.
In the current research the investigator will investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.
Read the detailed description
The aim of our study is to investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.
In total 340 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. the investigators will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT). In addition information about the course and results of cardiac catheterization will be collected.
- Being tested
- Calibrated Automated Thrombogram
- Keywords
- thrombin generation, calibrated automated thrombogram, ischemic heart disease, Percutaneous Coronary Intervention
- Medical subject headings
- Hemostatic Disorders, Myocardial Ischemia, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calibrated Automated ThrombogramDevice
blood samples will be collected . Thrombin generation in platelet-poor plasma will be measured by means of the Calibrated Automated Thrombogram (CAT).
What is being measured
The primary outcome is the main question the study is designed to answer.
significant coronary lesion=>70% stenosis or =>50% stenosis in left main.
coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients
Measured: 1 week
syntax score.
coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients
Measured: 1 week
Secondary outcomes (2)
The number of stenotic coronary arteries
the number of stenotic vessels in ischemic heart disease patients
Measured: 1 week
Major adverse cardiac events (MACE)
MACE include acute coronary syndrome, cerebral vascular accident , revascularization, death from any cause
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 posted5 Jan 2018
- Study start1 Apr 2018
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DisorderStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boaz Elad, MD, Principal investigator, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391622
- Sponsor's protocol ID
- EMC166-17
- Status last verified
- Nov 2022
- First submitted
- 7 Dec 2017
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Thrombin Generation Values and Percutaneous Coronary Intervention Results in Active Ischemic Heart Disease Patients.
- ClinicalTrials.gov ID
- NCT03391622
- Acronym / sponsor ID
- EMC166-17
- Keywords
- thrombin generation, calibrated automated thrombogram, ischemic heart disease, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 5 Jan 2018 (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.
Cardiovascular diseases are the most common cause of death in the western world. Myocardial infarction pathogenesis usually involves the development of an atherosclerotic plaque and thrombus.
Past research has shown a correlation between thrombin generation values and ischemic heart disease, however, to our knowledge no investigation has been done into the correlation of thrombin generation and cardiac catheterization results in ischemic heart disease patients.
In the current research the investigator will investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.
Detailed description
The aim of our study is to investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.
In total 340 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. the investigators will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT). In addition information about the course and results of cardiac catheterization will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult with Acute coronary syndrome: ST segment elevation myocardial infraction, unstable angina, non ST elevation myocardial infraction or patients presented with chest pain suspect for acute coronary syndrome .
Key inclusion criteria (3 listed)
- Acute coronary syndrome: ST segment elevation myocardial infraction, unstable angina, non ST elevation myocardial infraction or patients presented with chest pain suspect for acute coronary syndrome .
- planned percutaneous coronary intervention.
- ability to give Informed consent.
Key exclusion criteria (6 listed)
- Acute coronary syndrome in the last 6 month prior to current event.
- thrombophilia
- pregnancy
- liver failure or cirrhosis
- anticoagulant current use
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 |
|---|---|---|
| Calibrated Automated Thrombogramblood samples will be collected . Thrombin generation in platelet-poor plasma will be measured by means of the Calibrated Automated Thrombogram (CAT). | Device | – |
Primary outcome
significant coronary lesion=>70% stenosis or =>50% stenosis in left main.
Time frame: 1 week
coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients
syntax score.
Time frame: 1 week
coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients
2 secondary outcomes
The number of stenotic coronary arteries
Time frame: 1 week
Major adverse cardiac events (MACE)
Time frame: 1 year
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 8 Nov 2022.
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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.
Boaz Elad, MD principal investigator
HaEmek Medical Center, Israel
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 Coagulation Disorder and Ischemic Heart Disease, 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 6 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 8 Nov 2022. 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?
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?
significant coronary lesion=>70% stenosis or =>50% stenosis in left main. (time frame: 1 week). 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 8 Nov 2022.