Ischemic StrokeNCT02964052
Selection Criteria in Endovascular Thrombectomy and Thrombolytic Therapy (SECRET) Study: Development of Patient Selection Criteria Using CT Images and Accompanying Diseases for Efficient Intravenous Thrombolytic and Intra-arterial Recanalization Therapy in Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by Yonsei University at 1 site in South Korea.
Trial summary
Use of intravenous (IV) thrombolysis and intra-arterial (IA) recanalization treatment has been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 - 70% and only 30-50% of patients show meaningful clinical improvements. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Brain CT imaging
- Type of treatment
- Injection or infusion
- How many people
- 1,359 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Nov 2016to 3 Aug 2020
- How long will I take part?
- 6 Months
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment
Who may be able to join
- Age ≥20 years old
- Acute ischemic stroke patients who underwent CT angiographies before IV thrombolysis and/or IA recanalization treatment
- Patients who give an informed consents for participation in the study or the legal representative or immediate family give informed consent on behalf of patients in case of difficulty to decide study enrollment.
Who cannot join
- Age <20 years old
- Acute ischemic stroke patients who did not receive IV thrombolysis and/or IA recanalization treatment
- No informed consents from patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Neurology, Yonsei University College of Medicine
Seoul, 120-752
About this study
Use of intravenous (IV) thrombolysis and intra-arterial (IA) recanalization treatment has been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 - 70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of comorbidity. In this regards, developing selection criteria using acute stroke imaging and comorbidity is warranted.
Investigators will recruit the consecutive acute stroke patients who received IV thrombolysis and/or IA recanalization treatment. This study will perform with prospective design to develop CT-based clot, core and collateral scores and a comorbidity index for selecting stroke patients who are at high risks by the treatment. Investigators will firstly establish the CT-based scores and comorbidity index using a pre-existing cohort database. Using these CT-based and comorbidity index, Investigators will validate them in a multi-center prospectively cohort. In addition, Investigators will assess the cost-effectiveness of selecting patients based on the comorbidity index.
- Conditions
- Ischemic Stroke
- Being tested
- Brain CT imaging
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain CT imagingOther
Investigators will analyzed the CT image that was performed in patients with hyperacute stroke. The CT protocol includes CT thrombus, collateral, core images. Investigators also obtain detailed history and laboratory and imaging result for comorbidity. The comorbidity index protocol is based on the Charlson comorbidity index.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke patients | Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment Receives: Other: Brain CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin scale scores
Measured: 3 months after discharge day
Death
Measured: 6 months after discharge day
National Institutes of Health Stroke Scale (NIHSS) scores
Measured: 1 hr after IV rt-PA infusion
Recanalization rate
Measured: after 16 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Recanalization rate
Measured: after 24 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Recanalization rate
Measured: after 32 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Symptomatic hemorrhagic transformation rate
Measured: after 16 hrs thrombolytic treatments in MR or CT
Symptomatic hemorrhagic transformation rate
Measured: after 24 hrs thrombolytic treatments in MR or CT
Symptomatic hemorrhagic transformation rate
Measured: after 32 hrs thrombolytic treatments in MR or CT
asymptomatic hemorrhagic transformation rate
Measured: after 16 hrs thrombolysis in MR or CT
asymptomatic hemorrhagic transformation rate
Measured: after 24 hrs thrombolysis in MR or CT
asymptomatic hemorrhagic transformation rate
Measured: after 32 hrs thrombolysis in MR or CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start18 Nov 2016
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,359 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964052
- Sponsor's protocol ID
- 4-2015-1196
- Status last verified
- Dec 2022
- First submitted
- 7 Nov 2016
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nam HS, Kim YD, Yoo J, Park H, Kim BM, Bang OY, Kim HC, Han E, Kim DJ, Lee IH, Lee H, Choi JK, Lee KY, Lee HS, Shin DH, Choi HY, Sohn SI, Hong JH, Lee JY, Baek JH, Kim GS, Seo WK, Chung JW, Kim SH, Song TJ, Han SW, Park JH, Kim J, Jung YH, Cho HJ, Ahn SH, Seo KD, Lee KO, Song J, Heo JH. d-Dimer Level After Endovascular Treatment Can Help Predict Outcome of Acute Ischemic Stroke. Stroke Vasc Interv Neurol. 2023 Feb 25;3(3):e000713. doi: 10.1161/SVIN.122.000713. eCollection 2023 May.
PubMed 41584989Kim HJ, Park MS, Yoo J, Kim YD, Park H, Kim BM, Bang OY, Kim HC, Han E, Kim DJ, Heo J, Choi JK, Lee KY, Lee HS, Shin DH, Choi HY, Sohn SI, Hong JH, Lee JY, Baek JH, Kim GS, Seo WK, Chung JW, Kim SH, Han SW, Park JH, Kim J, Jung YH, Cho HJ, Ahn SH, Lee SI, Seo KD, Chang Y, Song TJ, Nam HS; SECRET Study Investigators. Association between CHADS2, CHA2DS2-VASc, ATRIA, and Essen Stroke Risk Scores and Unsuccessful Recanalization after Endovascular Thrombectomy in Acute Ischemic Stroke Patients. J Clin Med. 2022 Jan 5;11(1):274. doi: 10.3390/jcm11010274.
PubMed 35012015
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection Criteria in Endovascular Thrombectomy and Thrombolytic Therapy (SECRET) Study: Development of Patient Selection Criteria Using CT Images and Accompanying Diseases for Efficient Intravenous Thrombolytic and Intra-arterial Recanalization Therapy in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02964052
- Acronym / sponsor ID
- 4-2015-1196
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,359 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 15 Nov 2016 (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.
Use of intravenous (IV) thrombolysis and intra-arterial (IA) recanalization treatment has been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 - 70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of comorbidity. In this regards, developing selection criteria using acute stroke imaging and comorbidity is warranted.
Investigators will recruit the consecutive acute stroke patients who received IV thrombolysis and/or IA recanalization treatment. This study will perform with prospective design to develop CT-based clot, core and collateral scores and a comorbidity index for selecting stroke patients who are at high risks by the treatment. Investigators will firstly establish the CT-based scores and comorbidity index using a pre-existing cohort database. Using these CT-based and comorbidity index, Investigators will validate them in a multi-center prospectively cohort. In addition, Investigators will assess the cost-effectiveness of selecting patients based on the comorbidity index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke patients | – | Other: Brain CT imagingAcute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment
Key inclusion criteria (3 listed)
- Age ≥20 years old
- Acute ischemic stroke patients who underwent CT angiographies before IV thrombolysis and/or IA recanalization treatment
- Patients who give an informed consents for participation in the study or the legal representative or immediate family give informed consent on behalf of patients in case of difficulty to decide study enrollment.
Key exclusion criteria (3 listed)
- Age <20 years old
- Acute ischemic stroke patients who did not receive IV thrombolysis and/or IA recanalization treatment
- No informed consents from patients
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 |
|---|---|---|
| Brain CT imagingInvestigators will analyzed the CT image that was performed in patients with hyperacute stroke. The CT protocol includes CT thrombus, collateral, core images. Investigators also obtain detailed history and laboratory and imaging result for comorbidity. The comorbidity index protocol is based on the Charlson comorbidity index. | Other | Acute ischemic stroke patients |
Primary outcome
Modified Rankin scale scores
Time frame: 3 months after discharge day
Death
Time frame: 6 months after discharge day
National Institutes of Health Stroke Scale (NIHSS) scores
Time frame: 1 hr after IV rt-PA infusion
Recanalization rate
Time frame: after 16 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Recanalization rate
Time frame: after 24 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Recanalization rate
Time frame: after 32 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Symptomatic hemorrhagic transformation rate
Time frame: after 16 hrs thrombolytic treatments in MR or CT
Symptomatic hemorrhagic transformation rate
Time frame: after 24 hrs thrombolytic treatments in MR or CT
Symptomatic hemorrhagic transformation rate
Time frame: after 32 hrs thrombolytic treatments in MR or CT
asymptomatic hemorrhagic transformation rate
Time frame: after 16 hrs thrombolysis in MR or CT
asymptomatic hemorrhagic transformation rate
Time frame: after 24 hrs thrombolysis in MR or CT
asymptomatic hemorrhagic transformation rate
Time frame: after 32 hrs thrombolysis in MR or CT
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 28 Dec 2022.
- Derived from this study: PubMed 41584989Nam HS, Kim YD, Yoo J, Park H, Kim BM, Bang OY, Kim HC, Han E, Kim DJ, Lee IH, Lee H, Choi JK, Lee KY, Lee HS, Shin DH, Choi HY, Sohn SI, Hong JH, Lee JY, Baek JH, Kim GS, Seo WK, Chung JW, Kim SH, Song TJ, Han SW, Park JH, Kim J, Jung YH, Cho HJ, Ahn SH, Seo KD, Lee KO, Song J, Heo JH. d-Dimer Level After Endovascular Treatment Can Help Predict Outcome of Acute Ischemic Stroke. Stroke Vasc Interv Neurol. 2023 Feb 25;3(3):e000713. doi: 10.1161/SVIN.122.000713. eCollection 2023 May.
- Derived from this study: PubMed 35012015Kim HJ, Park MS, Yoo J, Kim YD, Park H, Kim BM, Bang OY, Kim HC, Han E, Kim DJ, Heo J, Choi JK, Lee KY, Lee HS, Shin DH, Choi HY, Sohn SI, Hong JH, Lee JY, Baek JH, Kim GS, Seo WK, Chung JW, Kim SH, Han SW, Park JH, Kim J, Jung YH, Cho HJ, Ahn SH, Lee SI, Seo KD, Chang Y, Song TJ, Nam HS; SECRET Study Investigators. Association between CHADS2, CHA2DS2-VASc, ATRIA, and Essen Stroke Risk Scores and Unsuccessful Recanalization after Endovascular Thrombectomy in Acute Ischemic Stroke Patients. J Clin Med. 2022 Jan 5;11(1):274. doi: 10.3390/jcm11010274.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ischemic Stroke, run by Yonsei University at 1 site in South Korea.
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 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: finished, as of the sponsor's last update on 28 Dec 2022. 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 South Korea. 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?
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?
Modified Rankin scale scores (time frame: 3 months after discharge day). The study lists 12 primary outcomes in all. 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 NCT02964052, which also lists 2 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 28 Dec 2022.