StrokeSHIVCNCT07207330
Stroke Code in Hospitals From Villavicencio, Colombia
An observational study of Stroke and Ischemic Stroke, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
Trial summary
This is a descriptive cross-sectional study to evaluate stroke events in a hospital in the Orinoco region. It is based on reviewing a database obtained by routinely uploading patient information. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Stroke, Ischemic Stroke
- How many people
- 100 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admited to the emergency room
Who may be able to join
- Adult
- Clinical diagnosis of stroke
- CT findings compatible with a stroke
Who cannot join
- Trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Harold Gaitan Sierra, MD contact
Colombia1 site, 1 recruiting
- Recruiting
Clinica Primavera
Villavicencio, Meta Department, 50001
Norton Perez, MD, 3112517471, norton.perez@hotmail.com
About this study
Official title: Stroke Code: an Observational Cross-sectional Trial in Hospitals From Villavicencio, Colombia
This is a descriptive cross-sectional study to evaluate stroke events in a hospital in the Orinoco region. It is based on reviewing a database obtained by routinely uploading patient information. The registry is designed to follow up on the activation of a stroke code for clinical purposes and as an internal communication strategy. All registries are reviewed monthly in a scientific committee to improve quality of healthcare, standardize therapeutic strategies, and optimize outcomes. The review of the registries will allow to recognize patterns of care, delays in treatment, and define adherence to guidelines.
Read the detailed description
Background: Data banks or stroke registries are collected in several countries worldwide, generating information that improves patient healthcare quality.
Aim: The study aims to describe the stroke registry of patients admitted to a high-median-complexity institution.
Methodology: We wil perform a cross-sectional trial. Demographic and disease data, as well as discharge outcomes, are systematically collected in the RES-Q database. The records from the study period will be downloaded in Excel for evaluation. Numeric variables were assessed in their central distribution and dispersion, while categorical variables were presented in frequency and proportion.
Reports of stroke events in Latin America are scarce, and none were from the Colombian Orinoco region, even though there are multiple publications in the scientific literature about the use of clinical registries for stroke.
- Conditions
- Stroke, Ischemic Stroke
- Keywords
- Stroke, Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Registries of patients admitted to the emergency room with stroke suspicion by neurological deficit or headache. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional condition
Modified Rankin in 3 or below
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Departamental de Villavicencio
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative University of Colombia, Clinica Primavera
- Responsible party
- Principal investigator, Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio
- Investigators
- Norton Perez, MD, Study chair, Hospital Departamental de Villavicencio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207330
- Sponsor's protocol ID
- GRIVI_2025_01_Stroke
- Acronym
- SHIVC
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data contains personal information of patients restricted to hospital officials.
Publications
Lou M, Ding J, Hu B, Zhang Y, Li H, Tan Z, Wan Y, Xu AD; Chinese Stroke Association Stroke Council Guideline Writing Committee. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update on organizational stroke management. Stroke Vasc Neurol. 2020 Sep;5(3):260-269. doi: 10.1136/svn-2020-000355. Epub 2020 Jul 8.
PubMed 32641444Dhand A, Reeves MJ, Mu Y, Rosner BA, Rothfeld-Wehrwein ZR, Nieves A, Dhongade VA, Jarman M, Bergmark RW, Semco RS, Ader J, Marshall BDL, Goedel WC, Fonarow GC, Smith EE, Saver JL, Schwamm LH, Sheth KN. Mapping the Ecological Terrain of Stroke Prehospital Delay: A Nationwide Registry Study. Stroke. 2024 Jun;55(6):1507-1516. doi: 10.1161/STROKEAHA.123.045521. Epub 2024 May 24.
PubMed 38787926Fasugba O, Sedani R, Mikulik R, Dale S, Varecha M, Coughlan K, McElduff B, McInnes E, Hladikova S, Cadilhac DA, Middleton S. How registry data are used to inform activities for stroke care quality improvement across 55 countries: A cross-sectional survey of Registry of Stroke Care Quality (RES-Q) hospitals. Eur J Neurol. 2024 Jan;31(1):e16024. doi: 10.1111/ene.16024. Epub 2023 Aug 21.
PubMed 37540834Gimenez-Munoz A, Ara JR, Abad Diez JM, Campello Morer I, Perez Trullen JM. Trends in stroke hospitalisation rates and in-hospital mortality in Aragon, 1998-2010. Neurologia (Engl Ed). 2018 May;33(4):224-232. doi: 10.1016/j.nrl.2016.06.013. Epub 2016 Aug 21. English, Spanish.
PubMed 27554162Posadas-Martinez ML, Vicens J, Dawidowski AR, Martinez Von Scheidt MA, Pagotto VL, Blugerman GA, Schpilberg MG, Gadano AC. The role of registries in improving health and bridging healthcare, research, education, innovation and development: a research department perspective. J Int Med Res. 2024 Mar;52(3):3000605241233140. doi: 10.1177/03000605241233140.
PubMed 38460545Matuja SS, Ngimbwa J, Andrew L, Shindika J, Nchasi G, Kasala A, Paul IK, Ndalahwa M, Mawazo A, Kalokola F, Ngoya P, Rudovick L, Kilonzo S, Wajanga B, Massaga F, Kalluvya SE, Munseri P, Mnacho MA, Okeng'o K, Kimambo H, Manji M, Ruggajo P, Nagu T, Ahmed RA, Sheriff F, Mahawish K, Mangat H, Nguyen-Huynh MN, Saylor D, Peck R. Stroke characteristics and outcomes in urban Tanzania: Data from the Prospective Lake Zone Stroke Registry. Int J Stroke. 2024 Jun;19(5):536-546. doi: 10.1177/17474930231219584. Epub 2023 Dec 16.
PubMed 38031727
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Code: an Observational Cross-sectional Trial in Hospitals From Villavicencio, Colombia
- ClinicalTrials.gov ID
- NCT07207330
- Acronym / sponsor ID
- SHIVC / GRIVI_2025_01_Stroke
- Conditions
- Stroke, Ischemic Stroke
- Keywords
- Stroke, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Departamental de VillavicencioUniversity, hospital or other
- Collaborators
- Cooperative University of Colombia, Clinica Primavera
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Oct 2025 (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.
This is a descriptive cross-sectional study to evaluate stroke events in a hospital in the Orinoco region. It is based on reviewing a database obtained by routinely uploading patient information. The registry is designed to follow up on the activation of a stroke code for clinical purposes and as an internal communication strategy. All registries are reviewed monthly in a scientific committee to improve quality of healthcare, standardize therapeutic strategies, and optimize outcomes. The review of the registries will allow to recognize patterns of care, delays in treatment, and define adherence to guidelines.
Detailed description
Background: Data banks or stroke registries are collected in several countries worldwide, generating information that improves patient healthcare quality.
Aim: The study aims to describe the stroke registry of patients admitted to a high-median-complexity institution.
Methodology: We wil perform a cross-sectional trial. Demographic and disease data, as well as discharge outcomes, are systematically collected in the RES-Q database. The records from the study period will be downloaded in Excel for evaluation. Numeric variables were assessed in their central distribution and dispersion, while categorical variables were presented in frequency and proportion.
Reports of stroke events in Latin America are scarce, and none were from the Colombian Orinoco region, even though there are multiple publications in the scientific literature about the use of clinical registries for stroke.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Registries of patients admitted to the emergency room with stroke suspicion by neurological deficit or headache. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admited to the emergency room
Key inclusion criteria (3 listed)
- Adult
- Clinical diagnosis of stroke
- CT findings compatible with a stroke
Key exclusion criteria (1 listed)
- Trauma
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
Functional condition
Time frame: 30 days
Modified Rankin in 3 or below
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Results publication: PubMed 32641444Lou M, Ding J, Hu B, Zhang Y, Li H, Tan Z, Wan Y, Xu AD; Chinese Stroke Association Stroke Council Guideline Writing Committee. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update on organizational stroke management. Stroke Vasc Neurol. 2020 Sep;5(3):260-269. doi: 10.1136/svn-2020-000355. Epub 2020 Jul 8.
- Results publication: PubMed 38787926Dhand A, Reeves MJ, Mu Y, Rosner BA, Rothfeld-Wehrwein ZR, Nieves A, Dhongade VA, Jarman M, Bergmark RW, Semco RS, Ader J, Marshall BDL, Goedel WC, Fonarow GC, Smith EE, Saver JL, Schwamm LH, Sheth KN. Mapping the Ecological Terrain of Stroke Prehospital Delay: A Nationwide Registry Study. Stroke. 2024 Jun;55(6):1507-1516. doi: 10.1161/STROKEAHA.123.045521. Epub 2024 May 24.
- Results publication: PubMed 37540834Fasugba O, Sedani R, Mikulik R, Dale S, Varecha M, Coughlan K, McElduff B, McInnes E, Hladikova S, Cadilhac DA, Middleton S. How registry data are used to inform activities for stroke care quality improvement across 55 countries: A cross-sectional survey of Registry of Stroke Care Quality (RES-Q) hospitals. Eur J Neurol. 2024 Jan;31(1):e16024. doi: 10.1111/ene.16024. Epub 2023 Aug 21.
- Results publication: PubMed 27554162Gimenez-Munoz A, Ara JR, Abad Diez JM, Campello Morer I, Perez Trullen JM. Trends in stroke hospitalisation rates and in-hospital mortality in Aragon, 1998-2010. Neurologia (Engl Ed). 2018 May;33(4):224-232. doi: 10.1016/j.nrl.2016.06.013. Epub 2016 Aug 21. English, Spanish.
- Results publication: PubMed 38460545Posadas-Martinez ML, Vicens J, Dawidowski AR, Martinez Von Scheidt MA, Pagotto VL, Blugerman GA, Schpilberg MG, Gadano AC. The role of registries in improving health and bridging healthcare, research, education, innovation and development: a research department perspective. J Int Med Res. 2024 Mar;52(3):3000605241233140. doi: 10.1177/03000605241233140.
- Results publication: PubMed 38031727Matuja SS, Ngimbwa J, Andrew L, Shindika J, Nchasi G, Kasala A, Paul IK, Ndalahwa M, Mawazo A, Kalokola F, Ngoya P, Rudovick L, Kilonzo S, Wajanga B, Massaga F, Kalluvya SE, Munseri P, Mnacho MA, Okeng'o K, Kimambo H, Manji M, Ruggajo P, Nagu T, Ahmed RA, Sheriff F, Mahawish K, Mangat H, Nguyen-Huynh MN, Saylor D, Peck R. Stroke characteristics and outcomes in urban Tanzania: Data from the Prospective Lake Zone Stroke Registry. Int J Stroke. 2024 Jun;19(5):536-546. doi: 10.1177/17474930231219584. Epub 2023 Dec 16.
- Individual participant dataSharing planned: Undecided. The data contains personal information of patients restricted to hospital officials.
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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.
Harold Gaitan Sierra, MD contact
Norton Perez, MD study chair
Hospital Departamental de Villavicencio
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 Stroke and Ischemic Stroke, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
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 1 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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 Colombia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norton Perez, MD (+573112517471, norton.perez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional condition (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07207330, which also lists 6 linked publications.
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 3 Oct 2025.