Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorBeijing Friendship Hospital

About this trial

The majority (\>80%) of strokes are of ischemic etiology, of which ≈15% to 20% are attributable to atherosclerosis of the extracranial carotid arteries. The primary goal in carotid artery revascularization is to prevent stroke in patients with carotid artery stenosis. Treatment options including carotid endarterectomy (CEA) and carotid artery stenting (CAS). Hence, the investigators aim to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints. Also, CEA and CAS result in different postoperative geometric features of carotid arteries that entail relevant modifications of rheological parameters, that may be associated with the risk of local complications and carotid artery restenosis. Finally, long-term and sustained cognitive benefits after carotid artery revascularization need further research and evidence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adult, Older Adult

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Change in cognitive score

Among those with flow failure (PWI "time to peak" (TTP) delay\>2 sec) and cognitive impairment (\>1.0 SD below age-matched norms) at baseline, cognitive change at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.

Time frame
1 year
2

Change in carotid stenosis

The stenosis of the carotid artery measured by contrast-enhanced CT will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.

Time frame
1 year
3

Change in wall shear stress(WSS)

The hemodynamics factors: wall shear stress (WSS) at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.

Time frame
1 year
4

Change in oscillatory shear index (OSI)

The hemodynamics factors: oscillatory shear index (OSI) at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.

Time frame
1 year

Secondary outcomes

1

Silent infarcts

MRI-determined silent infarcts present at 1 year that were not present at baseline, comparing by treatment group

Time frame
1 year
2

White matter hyperintensity (WMH) volume

change in confluent white matter hyperintensity volume at 1 year, comparing by treatment group

Time frame
1 year
3

Major adverse cardiovascular events

The major adverse cardiovascular events at 1 year, comparing by treatment group

Time frame
1 year
4

The mortality rate

The mortality rate at 1 year, comparing by treatment group

Time frame
1 year

Other outcomes

Sponsors and contacts

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