Trial Outcomes & Findings for Vascular Ultrasound Screening in Patients With Ischemic Cerebrovascular Disease: a Multi-center Registry Study (NCT NCT02397655)

NCT ID: NCT02397655

Last Updated: 2016-11-04

Results Overview

By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, \<50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion. By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion. Patients with one of the above arteries having \>50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree.

• Recruitment status: COMPLETED
• Target enrollment: 12012 participants
• Primary outcome timeframe: 30 days after subjects recruitment
• Results posted on: 2016-11-04

Participant Flow

Participant milestones

Measure	Overall Study This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
Overall Study STARTED	12012
Overall Study COMPLETED	10711
Overall Study NOT COMPLETED	1301

Reasons for withdrawal

Measure	Overall Study This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
Overall Study data not completed	1301

Baseline Characteristics

Vascular Ultrasound Screening in Patients With Ischemic Cerebrovascular Disease: a Multi-center Registry Study

Baseline characteristics by cohort

Measure	Overall Study n=10711 Participants This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
Age, Continuous	64.1 years STANDARD_DEVIATION 10.9 • n=93 Participants
Sex: Female, Male Female	3628 Participants n=93 Participants
Sex: Female, Male Male	7083 Participants n=93 Participants
Region of Enrollment China	10711 participants n=93 Participants

PRIMARY outcome

Timeframe: 30 days after subjects recruitment

Population: We provide the vessel numbers with its stenosis degree ≥50% stenosis (including occlusion).

By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, <50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion.

By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion.

Patients with one of the above arteries having >50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree.

Outcome measures

Measure	Overall Study n=10711 Participants This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography common carotid artery ≥50% stenosis	96 artery numbers
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography internal carotid artery ≥50% stenosis	1063 artery numbers
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography excranial vertebral artery ≥50% stenosis	826 artery numbers
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography subclavian artery ≥50% stenosis	241 artery numbers
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography middle cerebral artery ≥50% stenosis	1810 artery numbers
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography intracranial segment of vertebral artery stenosis	777 artery numbers
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography basilar artery ≥50% stenosis	324 artery numbers

Adverse Events

Overall Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yang Hua

Xuanwu hospital, Capital medical university

Phone: 86-10-83198923

Email: dryanghua99@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60