Coronary ThrombosisNCT02591264
Periprocedural Myocardial Infarction: the Role of Human Neutrophil Peptide-1 to 3
An observational study of Coronary Thrombosis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the occurrence of periprocedural myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Thrombosis
- What is being tested?
- Blood sample
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2015to Nov 2016
- 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: Troponin negative patients assigned for stent implantation in our medical institution.
Who may be able to join
- Troponin negative patients
- Stable angina
- Unstable angina
- Positive screening tests
Who cannot join
- Troponin positive
- Technical failure of procedure
- Hemodynamic unstability
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Rami Abu Fanne, MD, PhD, 972-50-3573694, ramia@hadassah.org.il
Rami Abu Fanne, MD, PhD
About this study
The aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the occurrence of periprocedural myocardial infarction.
- Conditions
- Coronary Thrombosis
- Being tested
- Blood sample
- Medical subject headings
- Coronary Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample drawn from participants for analysis of neutrophil peptide level
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Neutrophil Peptide Level
Laboratory analysis and measurement of Human Neutrophil Peptide-1 to 3 levels
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 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
- NCT02591264
- Sponsor's protocol ID
- 90-14-HYMC
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprocedural Myocardial Infarction: the Role of Human Neutrophil Peptide-1 to 3
- ClinicalTrials.gov ID
- NCT02591264
- Acronym / sponsor ID
- 90-14-HYMC
- Conditions
- Coronary Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 29 Oct 2015 (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.
The aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the occurrence of periprocedural myocardial infarction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Troponin negative patients assigned for stent implantation in our medical institution.
Key inclusion criteria (4 listed)
- Troponin negative patients
- Stable angina
- Unstable angina
- Positive screening tests
Key exclusion criteria (3 listed)
- Troponin positive
- Technical failure of procedure
- Hemodynamic unstability
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 |
|---|---|---|
| Blood sampleBlood sample drawn from participants for analysis of neutrophil peptide level | Other | – |
Primary outcome
Human Neutrophil Peptide Level
Time frame: Two hours
Laboratory analysis and measurement of Human Neutrophil Peptide-1 to 3 levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
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 Coronary Thrombosis, 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 4 inclusion and 3 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 29 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 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 Rami Abu Fanne, MD, PhD (972-50-3573694, ramia@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Neutrophil Peptide Level (time frame: Two hours). 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 29 Oct 2015.