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Ischemic StrokeSPIRITNCT06783049

Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack With an Intelligent Management System

A study testing Cerebrovascular Disease Secondary Prevention Smart Management System in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by Beijing Tiantan Hospital at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to develop a digital health-based intelligent management system for the secondary prevention of ischemic stroke and to evaluate its effectiveness through a multicenter randomized controlled trial, assessing its health economic value. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cerebrovascular Disease Secondary Prevention Smart Management System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,490 participants
Where
3 sitesChina
Study dates
3 Mar 2025to 31 Jan 2027
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Patients diagnosed with acute ischemic stroke or transient ischemic attack.
  • Time from onset to enrollment ≤ 14 days.
  • Presence of at least one modifiable risk factor (hypertension, diabetes).
  • Ability to independently use a smartphone to complete system tasks upon discharge, or with the assistance of family members.
  • Signed informed consent by the patient or their family members.

Who cannot join

  • Patients already enrolled in other stroke-related healthcare quality improvement projects or clinical trials.
  • Patients or family members who refuse to sign the informed consent form.
  • Pregnant or breastfeeding women.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China3 sites, 1 recruiting
  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality

    Active, not recruiting
  • Beijing Tiantan Hospital

    Beijing, 100070

    Zhiyuan Feng, +86 15801290121, fzyhhz1996@gmail.com

    Recruiting
  • The First Affiliated Hospital of Shihezi University

    Shihezi, Xinjiang

    Active, not recruiting

Other trials in China

About this study

Official title: Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack With an Intelligent System

The purpose of this study is to develop a digital health-based intelligent management system for the secondary prevention of ischemic stroke and to evaluate its effectiveness through a multicenter randomized controlled trial, assessing its health economic value.

Participants will receive usual care after discharge (control group) or be managed with a WeChat-based intelligent management system after discharge (intervention group).

At one year, all patients will undergo face-to-face follow-up to assess clinical events, medication adherence, and the achievement of target risk factor levels.

Read the detailed description

Before discharge, patients receive standard education on the secondary prevention of ischemic stroke from their physician, covering topics such as secondary prevention medications, risk factor management, lifestyle modifications, and rehabilitation. Additionally, the "Intelligent Management System," a WeChat-based applet, is activated for each patient. The system records basic patient information and integrates with mobile IoT devices, such as blood pressure monitors and glucose meters, allowing for self-monitoring of risk factors post-discharge. Based on international guidelines, high-level evidence, and the expertise of stroke specialists, a comprehensive clinical decision-making tree is established. This serves as the foundation for an AI feedback system that provides intelligent feedback on risk factor control and predicts recurrence risk. The patient interface includes educational content on ischemic stroke, risk factor management, lifestyle adjustments, and follow-up schedules post-discharge.

The system also features a physician interface, which enables attending doctors to offer online consultations, schedule face-to-face follow-up appointments, and manage patients long-term. Each patient is assigned to an "Online Stroke Care Team," which includes a "Health Management Officer" responsible for facilitating communication between the patient and the physician and providing basic health guidance. Additionally, an "Online Doctor" is available to answer stroke-related medical questions.

The Health Management Officer monitors patients' health data and arranges online or in-person consultations for those with poor adherence or suboptimal target achievement. Patient management is guided by the theory of health empowerment, creating an integrated online and offline ischemic stroke management intervention model.

Being tested
Cerebrovascular Disease Secondary Prevention Smart Management System
Keywords
ischemic stroke, secondary prevention, digital health
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cerebrovascular Disease Secondary Prevention Smart Management SystemBehavioural

    The continuous post-discharge intervention for patients was conducted using the Cerebrovascular Disease Secondary Prevention Smart Management System. This system, integrated with a WeChat-based applet, records patients' basic information and connects with mobile IoT devices such as blood pressure monitors and glucose meters. This allows patients to self-monitor their risk factors post-discharge. Based on international guidelines, high-level evidence, and the clinical expertise of cerebrovascular specialists, a comprehensive clinical decision-making tree was developed. This serves as the foundation for an AI feedback system that provides intelligent feedback on risk factor control and predicts the risk of recurrence.

Study groups in NCT06783049
Study groupRoleWhat they receive
Control groupNo interventionPatients in the control group received secondary stroke prevention discharge recommendations from their attending physicians, based on standard medical practice. No additional interventions for secondary prevention were applied throughout the study.
Intervention groupExperimentalNot described
Receives: Behavioral: Cerebrovascular Disease Secondary Prevention Smart Management System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vascular events and all-causes death

    Vascular and all-cause mortality events were collected for one year post-enrollment through face-to-face follow-ups and patient self-reports. Vascular events included stroke recurrence, transient ischemic attacks, myocardial infarction, vascular interventions or surgeries, and systemic embolism. If a patient experienced both a vascular event and death, only one event was recorded. In cases of multiple vascular events, only the first event was documented.

    Measured: From enrollment to 1 year follow-up

  2. Risk factor control rate

    Risk factor control was defined as achieving glycated hemoglobin (HbA1c) ≤7% or blood pressure below the target set at discharge. If a patient had both hypertension and diabetes at enrollment, meeting the criteria for both conditions was considered two achieved targets. If the patient had only hypertension or diabetes at enrollment, meeting the target for the respective condition was considered one achieved target.

    Measured: From enrollment to 1 year follow-up

Secondary outcomes (16)
  1. Readmission to hospital within 1 year

    Measured: From enrollment to 1 year follow-up

  2. Stroke-related readmission

    Measured: From enrollment to 1 year follow-up

  3. Direct medical costs

    Measured: From enrollment to 1 year follow-up

  4. Rate of good adherence to secondary prevention medicine

    Measured: From enrollment to 1 year follow-up

  5. Adverse drug reaction

    Measured: From enrollment to 1 year follow-up

  6. Body mass index

    Measured: From enrollment to 1 year follow-up

  7. Waist circumstance

    Measured: From enrollment to 1 year follow-up

  8. Frequency of blood pressure monitoring

    calculated as time/week

    Measured: From enrollment to 1 year follow-up

  9. Frequency of blood glucose monitoring

    calculated as time/week

    Measured: From enrollment to 1 year follow-up

  10. Blood lipid levels

    Included total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceridee

    Measured: From enrollment to 1 year follow-up

  11. Rehabilitation

    Measured: From enrollment to 1 year follow-up

  12. Smoking

    Measured: From enrollment to 1 year follow-up

  13. Alcohol

    Measured: From enrollment to 1 year follow-up

  14. Regular exercise

    Measured: From enrollment to 1 year follow-up

  15. Overall physical activity level

    Assessed by IPAQ-S, calculated as MET-min/week

    Measured: From enrollment to 1 year follow-up

  16. Fatigue

    Assessed by Fatigue Severity Scale (FSS). Fatigue was defined as total FSS score ≥36

    Measured: From enrollment to 1 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start3 Mar 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,490 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06783049
Sponsor's protocol ID
2022YFC250494
Acronym
SPIRIT
Status last verified
Feb 2025
First submitted
14 Jan 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bonura A, Motolese F, Capone F, Iaccarino G, Alessiani M, Ferrante M, Calandrelli R, Di Lazzaro V, Pilato F. Smartphone App in Stroke Management: A Narrative Updated Review. J Stroke. 2022 Sep;24(3):323-334. doi: 10.5853/jos.2022.01410. Epub 2022 Sep 30.

    PubMed 36221935
  • Schwamm LH. Digital Health Strategies to Improve Care and Continuity Within Stroke Systems of Care in the United States. Circulation. 2019 Jan 8;139(2):149-151. doi: 10.1161/CIRCULATIONAHA.117.029234. No abstract available.

    PubMed 30615498
  • Requena M, Montiel E, Baladas M, Muchada M, Boned S, Lopez R, Rodriguez-Villatoro N, Juega J, Garcia-Tornel A, Rodriguez-Luna D, Pagola J, Rubiera M, Molina CA, Ribo M. Farmalarm. Stroke. 2019 Jul;50(7):1819-1824. doi: 10.1161/STROKEAHA.118.024355. Epub 2019 Jun 6.

    PubMed 31167621
  • Kim BJ, Park JM, Park TH, Kim J, Lee J, Lee KJ, Lee J, Chae JE, Thabane L, Lee J, Bae HJ. Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial. PLoS One. 2020 Mar 11;15(3):e0229483. doi: 10.1371/journal.pone.0229483. eCollection 2020.

    PubMed 32160205
  • Allan LP, Beilei L, Cameron J, Olaiya MT, Silvera-Tawil D, Adcock AK, English C, Gall SL, Cadilhac DA. A Scoping Review of mHealth Interventions for Secondary Prevention of Stroke: Implications for Policy and Practice. Stroke. 2023 Nov;54(11):2935-2945. doi: 10.1161/STROKEAHA.123.043794. Epub 2023 Oct 6.

    PubMed 37800373
  • Ahmadi M, Laumeier I, Ihl T, Steinicke M, Ferse C, Endres M, Grau A, Hastrup S, Poppert H, Palm F, Schoene M, Seifert CL, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Algra A, Amarenco P, Greving JP, Busse O, Kohler F, Marx P, Audebert HJ. A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial. Lancet Neurol. 2020 Jan;19(1):49-60. doi: 10.1016/S1474-4422(19)30369-2. Epub 2019 Nov 7.

    PubMed 31708447
  • Duncan PW, Bushnell CD, Jones SB, Psioda MA, Gesell SB, D'Agostino RB Jr, Sissine ME, Coleman SW, Johnson AM, Barton-Percival BF, Prvu-Bettger J, Calhoun AG, Cummings DM, Freburger JK, Halladay JR, Kucharska-Newton AM, Lundy-Lamm G, Lutz BJ, Mettam LH, Pastva AM, Xenakis JG, Ambrosius WT, Radman MD, Vetter B, Rosamond WD; COMPASS Site Investigators and Teams.. Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study. Circ Cardiovasc Qual Outcomes. 2020 Jun;13(6):e006285. doi: 10.1161/CIRCOUTCOMES.119.006285. Epub 2020 Jun 1.

    PubMed 32475159
  • Ihl T, Ahmadi M, Laumeier I, Steinicke M, Ferse C, Klyscz P, Endres M, Hastrup S, Poppert H, Palm F, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Audebert HJ. Patient-Centered Outcomes in a Randomized Trial Investigating a Multimodal Prevention Program After Transient Ischemic Attack or Minor Stroke: The INSPiRE-TMS Trial. Stroke. 2022 Sep;53(9):2730-2738. doi: 10.1161/STROKEAHA.120.037503. Epub 2022 Jun 15.

    PubMed 35703097
  • Song J, Wang X, Wang B, Ge Y, Bi L, Jing F, Jin H, Li T, Gu B, Wang L, Hao J, Zhao Y, Liu J, Zhang H, Li X, Li J, Ma W, Wang J, Normand ST, Herrin J, Armitage J, Krumholz HM, Zheng X; LIGHT Collaborative Group. Learning implementation of a guideline based decision support system to improve hypertension treatment in primary care in China: pragmatic cluster randomised controlled trial. BMJ. 2024 Jul 23;386:e079143. doi: 10.1136/bmj-2023-079143.

    PubMed 39043397
  • Chow CK, Klimis H, Thiagalingam A, Redfern J, Hillis GS, Brieger D, Atherton J, Bhindi R, Chew DP, Collins N, Andrew Fitzpatrick M, Juergens C, Kangaharan N, Maiorana A, McGrady M, Poulter R, Shetty P, Waites J, Hamilton Craig C, Thompson P, Stepien S, Von Huben A, Rodgers A; TEXTMEDS Investigators*. Text Messages to Improve Medication Adherence and Secondary Prevention After Acute Coronary Syndrome: The TEXTMEDS Randomized Clinical Trial. Circulation. 2022 May 10;145(19):1443-1455. doi: 10.1161/CIRCULATIONAHA.121.056161. Epub 2022 May 9.

    PubMed 35533220
  • Dorje T, Zhao G, Tso K, Wang J, Chen Y, Tsokey L, Tan BK, Scheer A, Jacques A, Li Z, Wang R, Chow CK, Ge J, Maiorana A. Smartphone and social media-based cardiac rehabilitation and secondary prevention in China (SMART-CR/SP): a parallel-group, single-blind, randomised controlled trial. Lancet Digit Health. 2019 Nov;1(7):e363-e374. doi: 10.1016/S2589-7500(19)30151-7. Epub 2019 Oct 10.

    PubMed 33323210
  • Schwarzbach CJ, Eichner FA, Rucker V, Hofmann AL, Keller M, Audebert HJ, von Bandemer S, Engelter ST, Geis D, Groschel K, Haeusler KG, Hamann GF, Meisel A, Sander D, Schutzmeier M, Veltkamp R, Heuschmann PU, Grau AJ; SANO study group. The structured ambulatory post-stroke care program for outpatient aftercare in patients with ischaemic stroke in Germany (SANO): an open-label, cluster-randomised controlled trial. Lancet Neurol. 2023 Sep;22(9):787-799. doi: 10.1016/S1474-4422(23)00216-8. Epub 2023 Jul 14.

    PubMed 37459876

Questions about this trial

What is this clinical trial studying?

A study testing Cerebrovascular Disease Secondary Prevention Smart Management System in people with Ischemic Stroke and Transient Ischemic Attack (TIA), run by Beijing Tiantan Hospital at 3 sites in China.

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 6 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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 Zhiyuan Feng, MD (86+15801290121, fzyhhz1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular events and all-causes death (time frame: From enrollment to 1 year follow-up). The study lists 2 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 NCT06783049, which also lists 12 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 21 Jan 2026.

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