Carotid Artery DiseasesHALONCT05539781
Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization
An observational study of Carotid Artery Diseases and Carotid Artery Stenosis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carotid Artery Diseases, Carotid Artery Stenosis, Cerebrovascular; Disorder, Arteriosclerotic
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2026
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, Older Adult
Who may be able to join
- Informed consent signed Patients with >=70% symptomatic or >=80% asymptomatic internal carotid stenosis
Who cannot join
- Incapability to give informed consent Previous disabling stroke Contralateral carotid occlusion or >70% stenosis Systemic disease judged non compatible with the procedures or randomization Suspected or manifested pregnancy General contraindications to MRI or CT studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Mingyuan Liu, PhD, +8613011157272, dr.mingyuanliiu@pku.edu.cn
About this study
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.
Read the detailed description
Hypothesis and Significance: We hypothesize that hemodynamically changes after carotid artery revascularization influence the cerebral function or carotid artery patency. If cognitive improvement or impairment and carotid artery restenosis can be demonstrated relate to hemodynamic remodeling in these patients, then we will have established a new prognostic factor for carotid revascularization independent of the existing study.
Specific Aim: 1) To compare the impact of carotid artery revascularization on long-term post-operative baroreceptor function and on cognitive brain function, and analyze their influence on clinical outcome. The specific goal is to assess the potential correlation between post-operative autonomic and cognitive function.
- To assess the solicitation on the carotid wall due to CAS as compared to CEA through structural analysis and mechanical modeling. The specific goal is to assess the potential correlation between stenting, wall damage, baroceptor impairment, and late neurological sequelae. 3) To assess the post-operative carotid hemodynamics combining medical image analysis, clinical data, and computer simulations. The specific goal aims at correlating both local (e.g., wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RRT)) and global phenomena (controlateral flow, arterial stiffening) with baroreflex function and post-operative neurological outcomes.
Cognitive Assessment. HALO will use existing cognitive assessment infrastructure. Cognitive assessments in our study must take place prior to revascularization or within two weeks after assignment to medical therapy alone. Testing is repeated at 44 days, and every year thereafter up to 4 years. At each test interval, a composite (mean) Z-score is derived from published normative samples for each test outcome. The primary outcome will be at 1 year in which the change in the composite Z-score from baseline will be calculated. Covariates will include age, education and depression. The test battery will be administered the same way for all enrolled patients. The cognitive domains being assessed in HALO are entirely consistent with those encompassed within the NINDS Common Data Elements (CDE).
Imaging protocol. Multimodal MRI, including routine parenchymal sequences and PWI utilizing dynamic susceptibility contrast technique, will be acquired at each participating HALO site. Imaging will take place within 14 days after HALO enrollment and prior to any intervention (carotid artery revascularization).
Standardized contrast agent injection protocol, appropriate preparation, and IV setup is used to ensure good scan quality. An antecubital vein IV catheter of 18-20 gauge is required. A test injection will be performed with approximately 10 ml of normal saline solution.
MRI image acquisition DWI/ADC (b=0, 1000 s/mm2 applied in each of three principal gradient directions), FLAIR, high-resolution T1, and GRE sequences will be acquired on 1.5-3.0 T scanners equipped with echo-planar imaging capability, using standard clinical protocols at participating HALO sites. Total scanning time will be approximately 40 minutes. PWI acquisition protocol will be standardized across all HALO sites, using sequential T2*-weighted (gradient echo) EPI time sequence scanning. A modified 2-phase contrast injection scheme will be used to perform CEMRA and DSC perfusion imaging, without need for additional contrast.
MRI structural analysis. silent infarct --- non-confluent hyperintense lesion >1mm on FLAIR sequence on 1-year MRI not present on baseline FLAIR MRI.
Cerebral microbleed - hypointense 1-2mm non-confluent lesion on baseline GRE sequence.
WMH volume -- White matter hyperintensity volume refers to confluent periventricular high intensity lesions on FLAIR imaging, and will be derived using an automated T2 WMH quantification at the Huston lab.
. Analysis. Specific Aim 1. To determine whether cognition can be improved by revascularization among a subset of HALO patients with hemodynamic changes at baseline.
The primary hypothesis is to assess if the magnitude of the treatment differences (revascularization versus medical management alone) differs between those with flow failure compared to those without flow failure using the Z-scored cognitive outcomes (C0, C(1). That is, the primary hypothesis is an interaction hypothesis that will be assessed using linear regression, specifically: (C1 - C0) = β0 + β1T + β2F + β3TF + β4C0 + (other covariates), where C1 is the cognitive z-score at year 1, C0 the cognitive z-score at baseline, T the treatment indicator variable, F the flow failure indicator variable, and βi the regression parameters to be estimated. The parameter of interest for the primary hypothesis is then β3 that would assess if the magnitude of treatment difference in the change in cognitive score between baseline and 1-year is similar for those with versus without flow failure.
Secondary Aims: To determine if the number of silent infarcts and white matter hyperintensity volume at 1 year is different between the revascularization and the medical-only arms.
For the secondary aims we will calculate the number of new silent cerebral infarctions occurring over the first year, and the change in the WMH volume. The approach for analysis of the number of new silent infarcts will depend on the average number and distribution of the number of new infarcts. The analytic approach will be linear regression if the number of new infarcts is large (considered more likely the case), or Poisson Regression if the number is smaller (considered less likely the case). The analysis of the change in WMH will use a linear regression approach.
- Conditions
- Carotid Artery Diseases, Carotid Artery Stenosis, Cerebrovascular; Disorder, Arteriosclerotic, Cardiovascular Diseases, Nervous System Diseases
- Keywords
- carotid endarterectomy, carotid stenting, computational fluid dynamic, cognitive function, medical therapy
- Medical subject headings
- Carotid Artery Diseases, Carotid Stenosis, Intracranial Arteriosclerosis, Cardiovascular Diseases, Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Change in relative residence time（RRT）
The hemodynamics factors: relative residence time (RRT)) at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
Measured: 1 year
Secondary outcomes (4)
Silent infarcts
MRI-determined silent infarcts present at 1 year that were not present at baseline, comparing by treatment group
Measured: 1 year
White matter hyperintensity (WMH) volume
change in confluent white matter hyperintensity volume at 1 year, comparing by treatment group
Measured: 1 year
Major adverse cardiovascular events
The major adverse cardiovascular events at 1 year, comparing by treatment group
Measured: 1 year
The mortality rate
The mortality rate at 1 year, comparing by treatment group
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539781
- Sponsor's protocol ID
- HALO
- Acronym
- HALO
- Status last verified
- May 2022
- First submitted
- 30 Aug 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Cutlip DE, Pinto DS. Extracranial carotid disease revascularization. Circulation. 2012 Nov 27;126(22):2636-44. doi: 10.1161/CIRCULATIONAHA.112.110411. No abstract available.
PubMed 23184283Auricchio F, Conti M, De Beule M, De Santis G, Verhegghe B. Carotid artery stenting simulation: from patient-specific images to finite element analysis. Med Eng Phys. 2011 Apr;33(3):281-9. doi: 10.1016/j.medengphy.2010.10.011. Epub 2010 Nov 9.
PubMed 21067964Conti M, Van Loo D, Auricchio F, De Beule M, De Santis G, Verhegghe B, Pirrelli S, Odero A. Impact of carotid stent cell design on vessel scaffolding: a case study comparing experimental investigation and numerical simulations. J Endovasc Ther. 2011 Jun;18(3):397-406. doi: 10.1583/10-3338.1.
PubMed 21679082Auricchio F, Conti M, Ferrara A, Morganti S, Reali A. Patient-specific finite element analysis of carotid artery stenting: a focus on vessel modeling. Int J Numer Method Biomed Eng. 2013 Jun;29(6):645-64. doi: 10.1002/cnm.2511. Epub 2012 Sep 29.
PubMed 23729192De Santis G, Conti M, Trachet B, De Schryver T, De Beule M, Degroote J, Vierendeels J, Auricchio F, Segers P, Verdonck P, Verhegghe B. Haemodynamic impact of stent-vessel (mal)apposition following carotid artery stenting: mind the gaps! Comput Methods Biomech Biomed Engin. 2013;16(6):648-59. doi: 10.1080/10255842.2011.629997. Epub 2011 Dec 8.
PubMed 22149183De Santis G, Trachet B, Conti M, De Beule M, Morbiducci U, Mortier P, Segers P, Verdonck P, Verhegghe B. A computational study of the hemodynamic impact of open- versus closed-cell stent design in carotid artery stenting. Artif Organs. 2013 Jul;37(7):E96-106. doi: 10.1111/aor.12046. Epub 2013 Apr 12.
PubMed 23578331Hathcock JJ. Flow effects on coagulation and thrombosis. Arterioscler Thromb Vasc Biol. 2006 Aug;26(8):1729-37. doi: 10.1161/01.ATV.0000229658.76797.30. Epub 2006 Jun 1.
PubMed 16741150Davies PF. Overview: temporal and spatial relationships in shear stress-mediated endothelial signalling. J Vasc Res. 1997 May-Jun;34(3):208-11. doi: 10.1159/000159224. No abstract available.
PubMed 9226302Bohm M, Cotton D, Foster L, Custodis F, Laufs U, Sacco R, Bath PM, Yusuf S, Diener HC. Impact of resting heart rate on mortality, disability and cognitive decline in patients after ischaemic stroke. Eur Heart J. 2012 Nov;33(22):2804-12. doi: 10.1093/eurheartj/ehs250. Epub 2012 Aug 26.
PubMed 22922507Irvine CD, Gardner FV, Davies AH, Lamont PM. Cognitive testing in patients undergoing carotid endarterectomy. Eur J Vasc Endovasc Surg. 1998 Mar;15(3):195-204. doi: 10.1016/s1078-5884(98)80176-7.
PubMed 9587331Hayase H, Tokunaga K, Nakayama T, Sugiu K, Nishida A, Arimitsu S, Hishikawa T, Ono S, Ohta M, Date I. Computational fluid dynamics of carotid arteries after carotid endarterectomy or carotid artery stenting based on postoperative patient-specific computed tomography angiography and ultrasound flow data. Neurosurgery. 2011 Apr;68(4):1096-101; discussion 1101. doi: 10.1227/NEU.0b013e318208f1a0.
PubMed 21221041Marshall RS, Lazar RM, Liebeskind DS, Connolly ES, Howard G, Lal BK, Huston J 3rd, Meschia JF, Brott TG. Carotid revascularization and medical management for asymptomatic carotid stenosis - Hemodynamics (CREST-H): Study design and rationale. Int J Stroke. 2018 Dec;13(9):985-991. doi: 10.1177/1747493018790088. Epub 2018 Aug 22.
PubMed 30132751Howard VJ, Meschia JF, Lal BK, Turan TN, Roubin GS, Brown RD Jr, Voeks JH, Barrett KM, Demaerschalk BM, Huston J 3rd, Lazar RM, Moore WS, Wadley VG, Chaturvedi S, Moy CS, Chimowitz M, Howard G, Brott TG; CREST-2 study investigators. Carotid revascularization and medical management for asymptomatic carotid stenosis: Protocol of the CREST-2 clinical trials. Int J Stroke. 2017 Oct;12(7):770-778. doi: 10.1177/1747493017706238. Epub 2017 May 2.
PubMed 28462683Schroder J, Heinze M, Gunther M, Cheng B, Nickel A, Schroder T, Fischer F, Kessner SS, Magnus T, Fiehler J, Larena-Avellaneda A, Gerloff C, Thomalla G. Dynamics of brain perfusion and cognitive performance in revascularization of carotid artery stenosis. Neuroimage Clin. 2019;22:101779. doi: 10.1016/j.nicl.2019.101779. Epub 2019 Mar 13.
PubMed 30903966Piegza M, Wieckiewicz G, Wierzba D, Piegza J. Cognitive Functions in Patients after Carotid Artery Revascularization-A Narrative Review. Brain Sci. 2021 Oct 1;11(10):1307. doi: 10.3390/brainsci11101307.
PubMed 34679372
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization
- ClinicalTrials.gov ID
- NCT05539781
- Acronym / sponsor ID
- HALO / HALO
- Conditions
- Carotid Artery Diseases, Carotid Artery Stenosis, Cerebrovascular; Disorder, Arteriosclerotic, Cardiovascular Diseases, Nervous System Diseases
- Keywords
- carotid endarterectomy, carotid stenting, computational fluid dynamic, cognitive function, medical therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis and Significance: We hypothesize that hemodynamically changes after carotid artery revascularization influence the cerebral function or carotid artery patency. If cognitive improvement or impairment and carotid artery restenosis can be demonstrated relate to hemodynamic remodeling in these patients, then we will have established a new prognostic factor for carotid revascularization independent of the existing study.
Specific Aim: 1) To compare the impact of carotid artery revascularization on long-term post-operative baroreceptor function and on cognitive brain function, and analyze their influence on clinical outcome. The specific goal is to assess the potential correlation between post-operative autonomic and cognitive function.
- To assess the solicitation on the carotid wall due to CAS as compared to CEA through structural analysis and mechanical modeling. The specific goal is to assess the potential correlation between stenting, wall damage, baroceptor impairment, and late neurological sequelae. 3) To assess the post-operative carotid hemodynamics combining medical image analysis, clinical data, and computer simulations. The specific goal aims at correlating both local (e.g., wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RRT)) and global phenomena (controlateral flow, arterial stiffening) with baroreflex function and post-operative neurological outcomes.
Cognitive Assessment. HALO will use existing cognitive assessment infrastructure. Cognitive assessments in our study must take place prior to revascularization or within two weeks after assignment to medical therapy alone. Testing is repeated at 44 days, and every year thereafter up to 4 years. At each test interval, a composite (mean) Z-score is derived from published normative samples for each test outcome. The primary outcome will be at 1 year in which the change in the composite Z-score from baseline will be calculated. Covariates will include age, education and depression. The test battery will be administered the same way for all enrolled patients. The cognitive domains being assessed in HALO are entirely consistent with those encompassed within the NINDS Common Data Elements (CDE).
Imaging protocol. Multimodal MRI, including routine parenchymal sequences and PWI utilizing dynamic susceptibility contrast technique, will be acquired at each participating HALO site. Imaging will take place within 14 days after HALO enrollment and prior to any intervention (carotid artery revascularization).
Standardized contrast agent injection protocol, appropriate preparation, and IV setup is used to ensure good scan quality. An antecubital vein IV catheter of 18-20 gauge is required. A test injection will be performed with approximately 10 ml of normal saline solution.
MRI image acquisition DWI/ADC (b=0, 1000 s/mm2 applied in each of three principal gradient directions), FLAIR, high-resolution T1, and GRE sequences will be acquired on 1.5-3.0 T scanners equipped with echo-planar imaging capability, using standard clinical protocols at participating HALO sites. Total scanning time will be approximately 40 minutes. PWI acquisition protocol will be standardized across all HALO sites, using sequential T2*-weighted (gradient echo) EPI time sequence scanning. A modified 2-phase contrast injection scheme will be used to perform CEMRA and DSC perfusion imaging, without need for additional contrast.
MRI structural analysis. silent infarct --- non-confluent hyperintense lesion >1mm on FLAIR sequence on 1-year MRI not present on baseline FLAIR MRI.
Cerebral microbleed - hypointense 1-2mm non-confluent lesion on baseline GRE sequence.
WMH volume -- White matter hyperintensity volume refers to confluent periventricular high intensity lesions on FLAIR imaging, and will be derived using an automated T2 WMH quantification at the Huston lab.
. Analysis. Specific Aim 1. To determine whether cognition can be improved by revascularization among a subset of HALO patients with hemodynamic changes at baseline.
The primary hypothesis is to assess if the magnitude of the treatment differences (revascularization versus medical management alone) differs between those with flow failure compared to those without flow failure using the Z-scored cognitive outcomes (C0, C(1). That is, the primary hypothesis is an interaction hypothesis that will be assessed using linear regression, specifically: (C1 - C0) = β0 + β1T + β2F + β3TF + β4C0 + (other covariates), where C1 is the cognitive z-score at year 1, C0 the cognitive z-score at baseline, T the treatment indicator variable, F the flow failure indicator variable, and βi the regression parameters to be estimated. The parameter of interest for the primary hypothesis is then β3 that would assess if the magnitude of treatment difference in the change in cognitive score between baseline and 1-year is similar for those with versus without flow failure.
Secondary Aims: To determine if the number of silent infarcts and white matter hyperintensity volume at 1 year is different between the revascularization and the medical-only arms.
For the secondary aims we will calculate the number of new silent cerebral infarctions occurring over the first year, and the change in the WMH volume. The approach for analysis of the number of new silent infarcts will depend on the average number and distribution of the number of new infarcts. The analytic approach will be linear regression if the number of new infarcts is large (considered more likely the case), or Poisson Regression if the number is smaller (considered less likely the case). The analysis of the change in WMH will use a linear regression approach.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, Older Adult
Key inclusion criteria (1 listed)
- Informed consent signed Patients with >=70% symptomatic or >=80% asymptomatic internal carotid stenosis
Key exclusion criteria (1 listed)
- Incapability to give informed consent Previous disabling stroke Contralateral carotid occlusion or >70% stenosis Systemic disease judged non compatible with the procedures or randomization Suspected or manifested pregnancy General contraindications to MRI or CT studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cognitive score
Time frame: 1 year
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.
Change in carotid stenosis
Time frame: 1 year
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.
Change in wall shear stress（WSS）
Time frame: 1 year
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.
Change in oscillatory shear index （OSI）
Time frame: 1 year
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.
Change in relative residence time（RRT）
Time frame: 1 year
The hemodynamics factors: relative residence time (RRT)) at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
4 secondary outcomes
Silent infarcts
Time frame: 1 year
White matter hyperintensity (WMH) volume
Time frame: 1 year
Major adverse cardiovascular events
Time frame: 1 year
The mortality rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 23184283Cutlip DE, Pinto DS. Extracranial carotid disease revascularization. Circulation. 2012 Nov 27;126(22):2636-44. doi: 10.1161/CIRCULATIONAHA.112.110411. No abstract available.
- Background: PubMed 21067964Auricchio F, Conti M, De Beule M, De Santis G, Verhegghe B. Carotid artery stenting simulation: from patient-specific images to finite element analysis. Med Eng Phys. 2011 Apr;33(3):281-9. doi: 10.1016/j.medengphy.2010.10.011. Epub 2010 Nov 9.
- Background: PubMed 21679082Conti M, Van Loo D, Auricchio F, De Beule M, De Santis G, Verhegghe B, Pirrelli S, Odero A. Impact of carotid stent cell design on vessel scaffolding: a case study comparing experimental investigation and numerical simulations. J Endovasc Ther. 2011 Jun;18(3):397-406. doi: 10.1583/10-3338.1.
- Background: PubMed 23729192Auricchio F, Conti M, Ferrara A, Morganti S, Reali A. Patient-specific finite element analysis of carotid artery stenting: a focus on vessel modeling. Int J Numer Method Biomed Eng. 2013 Jun;29(6):645-64. doi: 10.1002/cnm.2511. Epub 2012 Sep 29.
- Background: PubMed 22149183De Santis G, Conti M, Trachet B, De Schryver T, De Beule M, Degroote J, Vierendeels J, Auricchio F, Segers P, Verdonck P, Verhegghe B. Haemodynamic impact of stent-vessel (mal)apposition following carotid artery stenting: mind the gaps! Comput Methods Biomech Biomed Engin. 2013;16(6):648-59. doi: 10.1080/10255842.2011.629997. Epub 2011 Dec 8.
- Background: PubMed 23578331De Santis G, Trachet B, Conti M, De Beule M, Morbiducci U, Mortier P, Segers P, Verdonck P, Verhegghe B. A computational study of the hemodynamic impact of open- versus closed-cell stent design in carotid artery stenting. Artif Organs. 2013 Jul;37(7):E96-106. doi: 10.1111/aor.12046. Epub 2013 Apr 12.
- Background: PubMed 16741150Hathcock JJ. Flow effects on coagulation and thrombosis. Arterioscler Thromb Vasc Biol. 2006 Aug;26(8):1729-37. doi: 10.1161/01.ATV.0000229658.76797.30. Epub 2006 Jun 1.
- Background: PubMed 9226302Davies PF. Overview: temporal and spatial relationships in shear stress-mediated endothelial signalling. J Vasc Res. 1997 May-Jun;34(3):208-11. doi: 10.1159/000159224. No abstract available.
- Background: PubMed 22922507Bohm M, Cotton D, Foster L, Custodis F, Laufs U, Sacco R, Bath PM, Yusuf S, Diener HC. Impact of resting heart rate on mortality, disability and cognitive decline in patients after ischaemic stroke. Eur Heart J. 2012 Nov;33(22):2804-12. doi: 10.1093/eurheartj/ehs250. Epub 2012 Aug 26.
- Background: PubMed 9587331Irvine CD, Gardner FV, Davies AH, Lamont PM. Cognitive testing in patients undergoing carotid endarterectomy. Eur J Vasc Endovasc Surg. 1998 Mar;15(3):195-204. doi: 10.1016/s1078-5884(98)80176-7.
- Background: PubMed 21221041Hayase H, Tokunaga K, Nakayama T, Sugiu K, Nishida A, Arimitsu S, Hishikawa T, Ono S, Ohta M, Date I. Computational fluid dynamics of carotid arteries after carotid endarterectomy or carotid artery stenting based on postoperative patient-specific computed tomography angiography and ultrasound flow data. Neurosurgery. 2011 Apr;68(4):1096-101; discussion 1101. doi: 10.1227/NEU.0b013e318208f1a0.
- Background: PubMed 30132751Marshall RS, Lazar RM, Liebeskind DS, Connolly ES, Howard G, Lal BK, Huston J 3rd, Meschia JF, Brott TG. Carotid revascularization and medical management for asymptomatic carotid stenosis - Hemodynamics (CREST-H): Study design and rationale. Int J Stroke. 2018 Dec;13(9):985-991. doi: 10.1177/1747493018790088. Epub 2018 Aug 22.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases and Carotid Artery Stenosis, run by Beijing Friendship Hospital at 1 site 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 1 inclusion and 1 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Mingyuan Liu, PhD (+8613011157272, dr.mingyuanliu@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive score (time frame: 1 year). The study lists 5 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 NCT05539781, which also lists 15 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 14 Sep 2022.