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
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Condition or disease |
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Healthy Subjects |

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 |
- 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).
- 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)).
- Prevalence of polyvascular lesions, including atherosclerotic stenosis and plaque; [ Time Frame: at baseline ]
- 4-year progression rate of atherosclerotic plaque in intracranial and carotidal arteries. [ Time Frame: 4 years ]
- Fatal or nonfatal MI; [ Time Frame: 4 years ]
- Fatal or nonfatal stroke; [ Time Frame: 4 years ]
- Transient ischemic attack (TIA) [ Time Frame: 4 years ]
- All causes of death (cardiovascular or noncardiovascular death); [ Time Frame: 4 years ]
- Hospitalizations for vascular events; [ Time Frame: 4 years ]
- 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.
- Other vascular events (PAD, subclavian steal syndrome and systemic thromboembolic events); [ Time Frame: 4 years ]
- New diagnosed diabetes mellitus; [ Time Frame: 4 years ]
- New diagnosed chronic kidney disease; [ Time Frame: 4 years ]
- Cognitive impairment measured by the Montreal Cognitive Assessment (MoCA). [ Time Frame: 4 years ]
Biospecimen Retention: Samples With DNA

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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 |
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.

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
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 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |