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出境医 / 临床实验 / The Role of Netrin -1 in Acute Coronary Syndrome (ACS-NETRİN-1)
The Role of Netrin -1 in Acute Coronary Syndrome (ACS-NETRİN-1)
Study Description
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Coronary Syndrome | Other: netrin-1 value on admission to hospital | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 238 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | PATIENT AND CONTROL GROUP will be divided into two. |
| Masking: | Single (Participant) |
| Masking Description: | Patient group; Those diagnosed with ACS over 18 years of age, planned angiography and accepted angiography. The control group consisted of volunteers without disease. |
| Primary Purpose: | Diagnostic |
| Official Title: | The Effect of Serum Netrin-1 Levels on Diagnosis and Prognosis in Patients Presenting to the Emergency Department With Acute Coronary Syndrome |
| Actual Study Start Date : | September 15, 2013 |
| Actual Primary Completion Date : | August 15, 2014 |
| Actual Study Completion Date : | June 15, 2018 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: ACS GRUP
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. |
Other: netrin-1 value on admission to hospital |
|
Active Comparator: plasebo grup
It consisted of those without any disease and netri-1 values at admission were compared with the uptake patient group.
|
Other: netrin-1 value on admission to hospital |
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients over the age of 18
- diagnose ACS
- patients undergoing angiography
Exclusion Criteria:
- CVE history
- Neurological disease
- Pregnancy and Lactation
- Liver failure
- Diagnosed malignity
- Use of anticonvulsant and nephrotoxic medication
- Chronic kidney disease
- Not having angiography
- Developing acute renal failure after angiography
- Patients who rejected to participate were excluded.
Contacts and Locations
Sponsors and Collaborators
Aksaray University Training and Research Hospital
Investigators
| Study Director: | Hüseyin Mutlu, MD | Aksaray/Turkey |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 18, 2019 | ||||
| First Posted Date ICMJE | July 19, 2019 | ||||
| Last Update Posted Date | July 19, 2019 | ||||
| Actual Study Start Date ICMJE | September 15, 2013 | ||||
| Actual Primary Completion Date | August 15, 2014 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Role of Netrin -1 in Acute Coronary Syndrome | ||||
| Official Title ICMJE | The Effect of Serum Netrin-1 Levels on Diagnosis and Prognosis in Patients Presenting to the Emergency Department With Acute Coronary Syndrome | ||||
| Brief 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: PATIENT AND CONTROL GROUP will be divided into two. Masking: Single (Participant)Masking Description: Patient group; Those diagnosed with ACS over 18 years of age, planned angiography and accepted angiography. The control group consisted of volunteers without disease. Primary Purpose: Diagnostic
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| Condition ICMJE | Acute Coronary Syndrome | ||||
| Intervention ICMJE | Other: netrin-1 value on admission to hospital | ||||
| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
238 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | June 15, 2018 | ||||
| Actual Primary Completion Date | August 15, 2014 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04027127 | ||||
| Other Study ID Numbers ICMJE | aksaray 2013-23 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | huseyin mutlu, Aksaray University Training and Research Hospital | ||||
| Study Sponsor ICMJE | Aksaray University Training and Research Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Aksaray University Training and Research Hospital | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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