Clinical trial NCT06902415: Application of QDSA Platform in Cerebrovascular Diseases
Official title: Research on the Application of Quantitative Digital Subtraction Angiography Hemodynamic Analysis Platform in Cerebrovascular Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Disease
Keywords: Cerebrovascular Disease
Quantitative Digital Subtraction Angiography
Hemodynamic
Stroke
Death
Outcome
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cerebrovascular disease can be evaluated for quantitative hemodynamic characteristics using QDSA.

Brief summary: Cerebrovascular diseases pose a major global public health challenge, characterized by exceptionally high mortality and disability rates, with their pathogenesis closely linked to hemodynamic abnormalities. The quantitative digital subtraction angiography (QDSA) analysis platform, leveraging its advantages of vessel modeling-free operation, high computational efficiency, and DSA-equivalent sensitivity, has emerged as a novel hemodynamic assessment method with significant clinical potential. This study aims to establish a cerebrovascular disease cohort incorporating QDSA parameters to systematically validate the clinical value of this technology in preoperative evaluation and surgical planning, thereby providing evidence-based insights for optimizing diagnostic and therapeutic strategies.

Detailed description: Study overview: This study will construct a prospective cohort dataset that comprehensively integrates DSA features, clinical baseline data, clinical manifestations, and follow-up data. Using QDSA technology, hemodynamic parameters of patients will be extracted. Based on multidimensional data, this study will conduct clinical research targeting different clinical scenarios, covering disease natural history evaluation, risk factor analysis, and treatment efficacy assessment. Through longitudinal tracking of data evolution and multidimensional parameter correlation analysis, this framework aims to establish an evidence-based pathway for translating hemodynamic characteristics into clinical decision-making, providing valuable references for clinical practice.

Sample size: Between February 2025 and February 2030, a total of 1000 patients with cerebrovascular diseases will be prospectively enrolled, including those with cerebral arteriovenous malformations (AVMs), cerebral aneurysms, moyamoya disease, cerebral arterial stenosis, ischemic stroke, and other subtypes.

Study endpoints: The primary outcome is defined as the composite endpoint of symptomatic stroke or death. And the secondary outcome included neurological status, assessed using the modified Rankin Scale (mRS).

Follow-up: Follow-up assessments will be conducted at 3 months, 6 months, annually (1 year, 2 years, and 3 years), and every 5 years after the initial treatment decision in the form of telephone interviews or record review. Individuals suspected of experiencing cerebrovascular events will undergo focused documentation during each telephone contact or record review.

Eligibility criteria: Inclusion Criteria:

1. Cerebrovascular diseases diagnosed and assessed by DSA for related risks and treatment options.
2. The DSA acquisition protocol complies with the standard procedure.
3. DSA images must include complete anteroposterior and lateral views.
4. Raw data must be available in DICOM format.
5. Image quality and pixel resolution must support data analysis.
6. Patients must undergo regular follow-ups.

Exclusion Criteria:

1. Cerebrovascular diseases not diagnosed or risk-assessed using DSA.
2. Patients with DSA image quality insufficient for image analysis and processing.
3. Severe organ diseases with an expected survival period of less than 2 years.
4. Inability to cooperate with treatment and follow-up.
5. Participation in other clinical trials within the past 6 months.
6. Other conditions deemed by the investigator as unsuitable for participation in this trial.

Primary outcomes:
measure: Symptomatic stroke or death
timeFrame: After treatment (max 10 years)
Secondary outcomes:
measure: Neurological status (modified Ranking Scale score)
timeFrame: After treatment (max 10 years)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: