Acute Coronary SyndromeACS-NETRİN-1NCT04027127
The Role of Netrin -1 in Acute Coronary Syndrome
A study testing netrin-1 value on admission to hospital in people with Acute Coronary Syndrome, run by Aksaray University Training and Research Hospital.
Trial summary
In our study, Netrin -1; We found that patients with ACS increased at the time of admission, decreased TIMI 3 flow after angiography, and higher risk groups in high risk groups such as TIMI and GRACE were found to have higher Netrin-1 levels. 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
- What is being tested?
- netrin-1 value on admission to hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2013to 15 Jun 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18
- diagnose ACS
- patients undergoing angiography
Who cannot join
- CVE history
- Neurological disease
- Pregnancy and Lactation
- Liver failure
- Diagnosed malignity
- Use of anticonvulsant and nephrotoxic medication
Show all 10Show fewer
- Chronic kidney disease
- Not having angiography
- Developing acute renal failure after angiography
- Patients who rejected to participate were excluded.
About this study
Official title: The Effect of Serum Netrin-1 Levels on Diagnosis and Prognosis in Patients Presenting to the Emergency Department With Acute Coronary Syndrome
In our study, Netrin -1; We found that patients with ACS increased at the time of admission, decreased TIMI 3 flow after angiography, and higher risk groups in high risk groups such as TIMI and GRACE were found to have higher Netrin-1 levels.
- Conditions
- Acute Coronary Syndrome
- Being tested
- netrin-1 value on admission to hospital
- Keywords
- netrin-1, acs, reperfuzion
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
netrin-1 value on admission to hospitalOther
| Study group | Role | What they receive |
|---|---|---|
| ACS GRUP | Active comparator | Demographic characteristics, history, vital signs, laboratory findings, coronary angiography (CAG) and echocardiography (ECO) findings of the patients were recorded. Netrin-1 levels were studied with blood collected at the hospital and 6-8 hours after CAG. CAG results were evaluated by TIMI flow. The patients were divided into two groups with and without TIMI 3 flow and Netrin-1 levels were compared.
GRACE (Global Registry of Acute Coronary Events) and TIMI (Thrombolysis in Myocardial Ischemia) clinical risk assessments were performed and Netrin-1 values were compared. Receives: Other: netrin-1 value on admission to hospital |
| plasebo grup | Active comparator | It consisted of those without any disease and netri-1 values at admission were compared with the uptake patient group. Receives: Other: netrin-1 value on admission to hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum netrin-1 value
Netrin-1 in plasma was measured by enzyme-linked immunosorbent assay (ELISA) (Mybıosource MBS044526 ) All assays were performed in duplicate. Plasma Netrin-1 is expressed in picograms (pg) per mg.
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start15 Sep 2013
- Primary completion15 Aug 2014
- Study completion15 Jun 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- PATIENT AND CONTROL GROUP will be divided into two.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, huseyin mutlu, Aksaray University Training and Research Hospital
- Investigators
- Hüseyin Mutlu, MD, Study director, Aksaray/Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027127
- Sponsor's protocol ID
- aksaray 2013-23
- Acronym
- ACS-NETRİN-1
- Status last verified
- Jul 2019
- First submitted
- 18 Jun 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Serum Netrin-1 Levels on Diagnosis and Prognosis in Patients Presenting to the Emergency Department With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04027127
- Acronym / sponsor ID
- ACS-NETRİN-1 / aksaray 2013-23
- Conditions
- Acute Coronary Syndrome
- Keywords
- netrin-1, acs, reperfuzion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Sep 2013 (actual)
- Primary completion
- 15 Aug 2014 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 19 Jul 2019 (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.
In our study, Netrin -1; We found that patients with ACS increased at the time of admission, decreased TIMI 3 flow after angiography, and higher risk groups in high risk groups such as TIMI and GRACE were found to have higher Netrin-1 levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- PATIENT AND CONTROL GROUP will be divided into two.
| Arm | Type | Receives |
|---|---|---|
| ACS GRUP | Active comparator | Other: netrin-1 value on admission to hospitalDemographic characteristics, history, vital signs, laboratory findings, coronary angiography (CAG) and echocardiography (ECO) findings of the patients were recorded. Netrin-1 levels were studied with blood collected at the hospital and 6-8 hours after CAG. CAG results were evaluated by TIMI flow. The patients were divided into two groups with and without TIMI 3 flow and Netrin-1 levels were compared. GRACE (Global Registry of Acute Coronary Events) and TIMI (Thrombolysis in Myocardial Ischemia) clinical risk assessments were performed and Netrin-1 values were compared. |
| plasebo grup | Active comparator | Other: netrin-1 value on admission to hospitalIt consisted of those without any disease and netri-1 values at admission were compared with the uptake patient group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18
- diagnose ACS
- patients undergoing angiography
Key exclusion criteria (10 listed)
- CVE history
- Neurological disease
- Pregnancy and Lactation
- Liver failure
- Diagnosed malignity
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 |
|---|---|---|
| netrin-1 value on admission to hospital | Other | ACS GRUP, plasebo grup |
Primary outcome
serum netrin-1 value
Time frame: 30 minute
Netrin-1 in plasma was measured by enzyme-linked immunosorbent assay (ELISA) (Mybıosource MBS044526 ) All assays were performed in duplicate. Plasma Netrin-1 is expressed in picograms (pg) per mg.
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 19 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Hüseyin Mutlu, MD study director
Aksaray/Turkey
Questions about this trial
What is this clinical trial studying?
A study testing netrin-1 value on admission to hospital in people with Acute Coronary Syndrome, run by Aksaray University Training and Research Hospital.
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 10 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
serum netrin-1 value (time frame: 30 minute). 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 19 Jul 2019.