Acute Coronary SyndromeNCT01233336
Hepatocyte Growth Factor (HGF) Concentration in Myocardial Infarction
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
This is the continuation of previous study (registration number: NCT00844987) which revealed that hepatocyte growth factor (HGF) is a very early, good marker of myocardial injury and prognostic factor for post myocardial infarction (MI) cardiovascular events presence in long-term follow-up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction
- How many people
- 45 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2010to Dec 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with acute coronary syndrome admitted to CCU due to symptoms of ACS.
Who may be able to join
- age >18 years,
- chest pain,
- symptoms of ischemia at ECG,
- signed informed consent form
Who cannot join
- age < 18 years,
- not signed informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatocyte Growth Factor as an Early Marker of Myocardial Injury and Prognostic Factor of Cardiovascular Events in Log-term Follow up in Patients With Acute Coronary Syndrome
This is the continuation of previous study (registration number: NCT00844987) which revealed that hepatocyte growth factor (HGF) is a very early, good marker of myocardial injury and prognostic factor for post myocardial infarction (MI) cardiovascular events presence in long-term follow-up. Due to potentially very important implication of the results of previous study it was decided to continue research of HGF in patients with MI. Now, is scheduled to examine 100 consecutive patients with STEMI. HGF assessments will be performed just after admission to hospital, 1h and 24h later and before discharge. Two follow-up visits were planned i.e. at 3 and 6 months after MI. During hospitalization and at 6 month visit the echocardiography examination will be performed. The composite primary endpoint consists of cardiovascular events observed during hospital course and in long term-follow-up.
Read the detailed description
Hepatocyte growth factor (HGF) was examined in study number NCT00844987 as a potentially useful marker of acute myocardial injury. Results of the study confirmed efficacy of HGF as very early marker of myocardial necrosis and as a prognostic factor for cardiovascular events in long term follow up. Recent study is a continuation of previous study.
The aim is to confirm that maximal values of the HGF in first examination performed in ACS (acute coronary syndrome) patients and to show predictive value of HGF for early and late outcome in patients with ACS.
Materials and method: 100 patients with acute coronary syndrome will be included into the study. HGF will be examined four times i.e. just after admission, 1h and 24h latter and before discharge. In case of 10 patients will be performed 10 assessments during first day of ACS.
The follow up visits will take place 3 and 6 months after ACS. During hospitalization and 6 months later echocardiography examination will be performed and the extension of heart dysfunction will be assessed. Control group will consist of 10-15 health volunteers.
The primary endpoint is a composite endpoint which will include following cardiovascular events observed during hospitalization and during 6-month follow up: death, reinfarction, coronary interventions (PCI and/or CABG) due to new ACS or exacerbation of angina, symptoms of heart failure, rehospitalization due to cardiovascular events and stroke in context of HGF concentration in acute stage of ACS.
As a secondary endpoints will be considered: 1) death, 2) symptoms of heart failure 3)rehospitalization due to cardiac events observed during hospitalization or in 6-month follow-up. All this endpoints will consider in context of HGF values and values of routinely measured markers of myocardial injury.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- ACS,, HGF,, myocardial infarction, markers of myocardial injury, acute coronary syndrome (ACS), prognostic factors in patients with ACS
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
composite end point
death, reinfarction, coronary interventions (PCI and/or CABG) due to new ACS or exacerbation of angina, symptoms of heart failure, rehospitalisation due to cardiovascular events and stroke in context of HGF concentration in acute stage of ACS
Measured: 6-month follow -up
Secondary outcomes (3)
death
endpoint in context of HGF concentration in early stage of ACS
Measured: 6- month follow-up
symptoms of heart failure
endpoint in context of HGF concentrationin early stage of ACS
Measured: 6-month follow-up
rehospitalisation due to cardiovascular reasons
endpoint in context of HGF concentration in early stage of ACS
Measured: 6- month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233336
- Sponsor's protocol ID
- 2.52/VII/10
- Status last verified
- Feb 2013
- First submitted
- 2 Nov 2010
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatocyte Growth Factor as an Early Marker of Myocardial Injury and Prognostic Factor of Cardiovascular Events in Log-term Follow up in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01233336
- Acronym / sponsor ID
- 2.52/VII/10
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- ACS,, HGF,, myocardial infarction, markers of myocardial injury, acute coronary syndrome (ACS), prognostic factors in patients with ACS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Nov 2010 (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 the continuation of previous study (registration number: NCT00844987) which revealed that hepatocyte growth factor (HGF) is a very early, good marker of myocardial injury and prognostic factor for post myocardial infarction (MI) cardiovascular events presence in long-term follow-up. Due to potentially very important implication of the results of previous study it was decided to continue research of HGF in patients with MI. Now, is scheduled to examine 100 consecutive patients with STEMI. HGF assessments will be performed just after admission to hospital, 1h and 24h later and before discharge. Two follow-up visits were planned i.e. at 3 and 6 months after MI. During hospitalization and at 6 month visit the echocardiography examination will be performed. The composite primary endpoint consists of cardiovascular events observed during hospital course and in long term-follow-up.
Detailed description
Hepatocyte growth factor (HGF) was examined in study number NCT00844987 as a potentially useful marker of acute myocardial injury. Results of the study confirmed efficacy of HGF as very early marker of myocardial necrosis and as a prognostic factor for cardiovascular events in long term follow up. Recent study is a continuation of previous study.
The aim is to confirm that maximal values of the HGF in first examination performed in ACS (acute coronary syndrome) patients and to show predictive value of HGF for early and late outcome in patients with ACS.
Materials and method: 100 patients with acute coronary syndrome will be included into the study. HGF will be examined four times i.e. just after admission, 1h and 24h latter and before discharge. In case of 10 patients will be performed 10 assessments during first day of ACS.
The follow up visits will take place 3 and 6 months after ACS. During hospitalization and 6 months later echocardiography examination will be performed and the extension of heart dysfunction will be assessed. Control group will consist of 10-15 health volunteers.
The primary endpoint is a composite endpoint which will include following cardiovascular events observed during hospitalization and during 6-month follow up: death, reinfarction, coronary interventions (PCI and/or CABG) due to new ACS or exacerbation of angina, symptoms of heart failure, rehospitalization due to cardiovascular events and stroke in context of HGF concentration in acute stage of ACS.
As a secondary endpoints will be considered: 1) death, 2) symptoms of heart failure 3)rehospitalization due to cardiac events observed during hospitalization or in 6-month follow-up. All this endpoints will consider in context of HGF values and values of routinely measured markers of myocardial injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome admitted to CCU due to symptoms of ACS.
Key inclusion criteria (4 listed)
- age >18 years,
- chest pain,
- symptoms of ischemia at ECG,
- signed informed consent form
Key exclusion criteria (2 listed)
- age < 18 years,
- not signed informed consent form.
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
composite end point
Time frame: 6-month follow -up
death, reinfarction, coronary interventions (PCI and/or CABG) due to new ACS or exacerbation of angina, symptoms of heart failure, rehospitalisation due to cardiovascular events and stroke in context of HGF concentration in acute stage of ACS
3 secondary outcomes
death
Time frame: 6- month follow-up
symptoms of heart failure
Time frame: 6-month follow-up
rehospitalisation due to cardiovascular reasons
Time frame: 6- month follow-up
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 5 Feb 2013.
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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?
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 2 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 5 Feb 2013. 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 Poland. 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?
composite end point (time frame: 6-month follow -up). 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 5 Feb 2013.