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出境医 / 临床实验 / BIO-PREDISC-TIA SWISS Cohort Study (PREDISC)
BIO-PREDISC-TIA SWISS Cohort Study (PREDISC)
Study Description
Brief Summary:
This research project aims at contributing to improve TIA diagnosis and management by using PREDISC scores and specific biomarkers thought to have elevated levels in TIA patients. A swift and accurate TIA diagnosis allows starting treatment of the patient adequately and shortly after the event. The shorter the time between the event and treatment onset, the better the outcome. This approach will be an important step forward in TIA diagnosis and management, similarly to acute coronary syndrome as discussed above.
| Condition or disease |
|---|
| Cerebrovascular Disease, Ischemic Stroke |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 120 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | BIOmarkers and PREDISC Diagnostic Evaluation for Patients With Suspected Transient Ischemic Attacks: the BIOPREDISC- TIA SWISS Cohort Study |
| Actual Study Start Date : | August 4, 2017 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2021 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Levels of specific biomarkers (Platelet Basic Protein (PBP), ceruloplasmin, microRNAs, exosomal particles) in patients with suspected TIA. [ Time Frame: 1 year ]Diagnostic performance according to PREDISC scale
Biospecimen Retention: Samples With DNA
MiRNA will be isolated from whole blood collected in PAXgene tubes (BD/PreAnalytiX, Franklin Lakes, NJ). PAXgene tubes contain an RNA stabilizing reagent that acts at time of blood draw to prevent RNA degradation. RNA in whole blood is derived mainly from peripheral blood cells (monocytes, neutrophils, T cells, B cells, and megakaryocytes).
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting <24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset.
Criteria
Inclusion Criteria:
-
Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting <24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset.
- At least 18 years old.
- Having given their Informed Consent.
Exclusion Criteria:
-
· Patients with ocular TIA (Amaurosis fugax).
- Patients that still have neurological deficits at the moment of inclusion.
- Contraindication to perform MRI.
- For women: pregnancy.
Contacts and Locations
Contacts
| Contact: Carlo Cereda, MD | +41918116691 | Carlo.Cereda@eoc.ch | |
| Contact: Concetta Manno, MD | +418116454 | Concetta.Manno@eoc.ch |
Locations
| Switzerland | |
| Ospedale Regionale di Lugano | Recruiting |
| Lugano, Ticino, Switzerland, 6900 | |
| Contact: Carlo W Cereda, MD Ph +41918116691 carlo.cereda@eoc.ch | |
| Contact: Jane M Frangi, RN +41918116050 janemarit.frangi-kultalahti@eoc.ch | |
| Sub-Investigator: Giovanni Bianco, MD | |
| Centre hospitalier Vaudois | Recruiting |
| Lausanne, Vaud, Switzerland, 1011 | |
| Contact: Patrik Michel, Prof. +41213141185 patrik.michel@chuv.ch | |
| Contact: Ashraf Eskandari +41213141265 ashraf.eskandari@chuv.ch | |
Sponsors and Collaborators
Dr. med. Carlo Cereda
Investigators
| Study Director: | Carlo Cereda, MD | Neurocentro della Svizzera Italiana Ospedale Regionale di Lugano |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 19, 2019 | ||||||||
| First Posted Date | June 21, 2019 | ||||||||
| Last Update Posted Date | June 21, 2019 | ||||||||
| Actual Study Start Date | August 4, 2017 | ||||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Levels of specific biomarkers (Platelet Basic Protein (PBP), ceruloplasmin, microRNAs, exosomal particles) in patients with suspected TIA. [ Time Frame: 1 year ] Diagnostic performance according to PREDISC scale
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | BIO-PREDISC-TIA SWISS Cohort Study | ||||||||
| Official Title | BIOmarkers and PREDISC Diagnostic Evaluation for Patients With Suspected Transient Ischemic Attacks: the BIOPREDISC- TIA SWISS Cohort Study | ||||||||
| Brief Summary | This research project aims at contributing to improve TIA diagnosis and management by using PREDISC scores and specific biomarkers thought to have elevated levels in TIA patients. A swift and accurate TIA diagnosis allows starting treatment of the patient adequately and shortly after the event. The shorter the time between the event and treatment onset, the better the outcome. This approach will be an important step forward in TIA diagnosis and management, similarly to acute coronary syndrome as discussed above. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
MiRNA will be isolated from whole blood collected in PAXgene tubes (BD/PreAnalytiX, Franklin Lakes, NJ). PAXgene tubes contain an RNA stabilizing reagent that acts at time of blood draw to prevent RNA degradation. RNA in whole blood is derived mainly from peripheral blood cells (monocytes, neutrophils, T cells, B cells, and megakaryocytes).
|
||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting <24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset. | ||||||||
| Condition | Cerebrovascular Disease, Ischemic Stroke | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
120 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2021 | ||||||||
| Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | Switzerland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03994003 | ||||||||
| Other Study ID Numbers | EOC.NSISU.4.12.99 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Dr. med. Carlo Cereda, Ospedale Civico, Lugano | ||||||||
| Study Sponsor | Dr. med. Carlo Cereda | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
||||||||
| PRS Account | Ospedale Civico, Lugano | ||||||||
| Verification Date | June 2019 | ||||||||
