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PolyvasculaR Evaluation for Cognitive Impairment and vaScular Events (PRECISE)

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ClinicalTrials.gov Identifier: NCT03178448
Recruitment Status : Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Yongjun Wang, Beijing Tiantan Hospital

Brief Summary:
The objective of this study is to characterize the prevalence of clinical or subclinical polyvascular lesions and 4-year progression rate of plaque in intracranial and carotidal arteries in a Chinese community population using vascular imaging techniques; to investigate the both traditional and emerging genetic, metabolomic, and environmental risk factors of presence and progression of intracranial and carotidal plaque; and to investigate the association between polyvascular lesions and future risk of cognitive impairment, cardio-/cerebrovascular events and death.

Condition or disease
Healthy Subjects

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Study Type : Observational
Actual Enrollment : 3067 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PolyvasculaR Evaluation for Cognitive Impairment and vaScular Events (PRECISE)
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : July 30, 2023



Primary Outcome Measures :
  1. New composite vascular event 1 [ Time Frame: 4 years ]
    Any new event of nonfatal stroke (ischemic or hemorrhagic), nonfatal myocardial infarction (MI) or cardiovascular death (including fatal stroke, fatal MI, and other cardiovascular death).

  2. New composite vascular event 2 [ Time Frame: 4 years ]
    Any new event of nonfatal stroke, nonfatal MI, cardiovascular death, vascular interventions (bypass graft, angioplasty, stent and amputation for ischemia), or hospitalizations for vascular events (including unstable angina pectoris, transient ischemic attack (TIA) and other ischemic arterial event including worsening of peripheral vascular disease (PAD)).


Secondary Outcome Measures :
  1. Prevalence of polyvascular lesions, including atherosclerotic stenosis and plaque; [ Time Frame: at baseline ]
  2. 4-year progression rate of atherosclerotic plaque in intracranial and carotidal arteries. [ Time Frame: 4 years ]
  3. Fatal or nonfatal MI; [ Time Frame: 4 years ]
  4. Fatal or nonfatal stroke; [ Time Frame: 4 years ]
  5. Transient ischemic attack (TIA) [ Time Frame: 4 years ]
  6. All causes of death (cardiovascular or noncardiovascular death); [ Time Frame: 4 years ]
  7. Hospitalizations for vascular events; [ Time Frame: 4 years ]
  8. Vascular interventions; [ Time Frame: 4 years ]
    Vascular interventions such as arterial bypass, balloon dilatation, stent implantation, carotid endarterectomy, mechanical thrombolysis and ischemic amputation.These events will be collected by self-reported by participants and confirmed by reviewing their medical records.

  9. Other vascular events (PAD, subclavian steal syndrome and systemic thromboembolic events); [ Time Frame: 4 years ]
  10. New diagnosed diabetes mellitus; [ Time Frame: 4 years ]
  11. New diagnosed chronic kidney disease; [ Time Frame: 4 years ]
  12. Cognitive impairment measured by the Montreal Cognitive Assessment (MoCA). [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA
Blood and urine samples will also be collected at baseline to test genetic and metabolomic markers.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The target population of the study consists of community population aged 50-75 years in Lishui city in southeast of China.
Criteria

Inclusion Criteria:

  • Community population in Lishui city;
  • Age between 50 and 75 years.

Exclusion Criteria:

  • Mental illness;
  • Advanced cancers or any disease that decreases life expectation to ≤4 years;
  • Allergy to iodine contrast, renal failure with creatinine clearance <60 mL/min, or blood urea nitrogen (BUN) or creatinine (CR) more than upper limit of the normal range that contraindicates CTA;
  • Pacemaker, implantable automatic defibrillator, or any implanted device that contraindicates MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178448


Locations
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China, Zhejiang
Lishui Hospital of Zhejiang University (the Central Hospital of Lishui)
Lishui, Zhejiang, China, 323000
China
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100050
Sponsors and Collaborators
Beijing Tiantan Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yongjun Wang, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03178448    
Other Study ID Numbers: 2016YFC0901001
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data can be requested through the website of the data management system (http://paper.ncrcnd.org.cn/) or by sending email to the principal investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders