Menu
Not yet recruiting NCT07097428

An Application Provides Temperature-related Health Risk Warnings and Protective Recommendations on Stroke

No phase Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Temperature health risk early warning.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Individualized Temperature Health Risk Early Warning for Reducing the Recurrence Risk of Stroke:A Multicenter, Randomized Controlled Trial Study

Overview

This study applied an application to provide early warnings and advice for stroke patients and explored the impact of this intervention on reducing the risk of stroke recurrence

Detailed description

This study applied an application that provides individualized environmental temperature-related health risk warnings and recommendations to stroke patients, enabling them to promptly understand their risk levels and take corresponding protective measures. And explore the effect of this actual intervention on reducing the risk of stroke recurrence after one year, as well as changes in other health-related indicators.

Interventions

  • Other Temperature health risk early warning
    Receive individualized temperature health risk warning through the application

Primary outcome measures

  • 1-year recurrence rate of stroke [Time frame: Intervention at the 1-year]
Secondary outcome measures (12)
  • 3-month, 6-month, 9-month recurrence rate of stroke [Time frame: Intervention at 3-month, 6-month, 9-month]
  • Blood pressure [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Electrocardiogram (ECG) parameters [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Environmental temperature health risk perception assessment questionnaire [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • System usability scale score [Time frame: Intervention at 3-month, 6-month, 9-month and 1-year]
  • Lipid Profile (Total Cholesterol, LDL-C, HDL-C, and Triglycerides) [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Fasting blood glucose [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Coagulation parameters (Prothrombin Time, aPTT, INR, Fibrinogen, Platelet Count and D-dimer) [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • C-reactive protein [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • Modified rankin scale score [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]
  • NIH stroke scale score [Time frame: Baseline]
  • European five-dimensional five-level health scale score [Time frame: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year]

Eligibility criteria

Inclusion criteria

  • Aged 40 to 80, with no gender restrictions;
  • Acute ischemic stroke inpatients within 2 weeks of onset, where the onset time is the time when stroke symptoms appear or the last known normal time of the patient (when it is an onset during sleep or the symptom onset time cannot be accurately obtained due to aphasia, impaired consciousness, etc.);
  • Confirmed diagnosis of ischemic stroke by CT or MRI of the brain within 2 weeks after symptom onset;
  • Local residents (residing for ≥6 months); ⑤ Patients who voluntarily participate in the study, have high compliance, and can sign the informed consent form;
  • Patients who own a smartphone or other smart devices.

Exclusion criteria

  • Patients diagnosed with other cerebrovascular diseases (hemorrhagic stroke, transient ischemic attack, cerebral venous sinus thrombosis, etc.) or non-cerebrovascular diseases;
  • Known pregnant or lactating women, or those who tested positive on a pregnancy test before cluster randomization;
  • Patients with other conditions that may affect participation in the trial (e.g., refractory hypertension, severe aphasia, etc.);
  • Patients undergoing psychiatric/psychological treatment that may contaminate the results; ⑤ Patients with a life expectancy of less than one year (e.g., coexisting malignant tumors, severe cardiopulmonary diseases, etc.); ⑥ Patients already participating in other interventional clinical studies that may influence the outcome assessment; ⑦ Patients for whom the investigator deems unsuitable for participation in this study or who may pose significant risks to the patients (e.g., cognitive impairment preventing understanding and/or compliance with the study procedures and/or follow-up).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07097428 · [2024]444-003-1-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗