Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-12 @ 11:44 PM
Study NCT ID:
NCT03735251
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2018-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Venous blood samples are obtained after an overnight fast. Total cholesterol, high-density lipoprotein cholesterol and triglycerides are measured by standard methods, and the Friedewald formula is used to calculate the lowdensity lipoprotein (LDL) cholesterol (LDL-c). Other biological parameters like plasma/urine albumin and creatinine are measured by standard methods at local laboratories. The urine albumin-to-creatinine ratio (UACR) is also calculated. The serum and urine samples will be stored at -80°C. Prior to storage, the date, number of vials and recorder's name will be recorded."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1920}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'left ventricular diastolic dysfunction', 'timeFrame': 'From July 2014 to August 2019', 'description': "All the ultrasonography measurements are performed with a MyLab 30 CV machine (ESAOTE SpA, Genoa, Italy), according to the American Society of Echocardiography (ASE) recommendations.The echocardiography is performed in the left decubitus position. Left ventricular (LV) internal diameter at end-diastole (LVIDd) and septal (SWTd) and posterior wall thickness at end-diastole (PWTd) are measured directly.\n\nleft ventricular diastolic dysfunction including: Impaired relaxation pattern：E/A\\< 1，DT \\> 220 ms，S/D \\> 1，AR 0.21-0.28 m/sec，E/e'\\<10 Pseudo-normalization pattern：E/A\\> 1，DT 150\\~210 ms，S/D \\< 1，AR ≥0.35m/sec，E/e'≥ 10 Restrictive pattern：E/A ≥ 2，DT \\< 150 ms，S/D \\<1，AR ≥0.25m/sec，E/e'≥10"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Left Ventricular Diastoic Dysfunction Cohort study'], 'conditions': ['Left Ventricular Diastoic Dysfunction Cohort Study']}, 'descriptionModule': {'briefSummary': "This study is one of the largest ongoing prospective population studies to evaluate target organ damages (TODs) and Left Ventricular Diastoic Dysfunction in the community-dwelling elderly Chinese, which is authorised and funded by the Shanghai municipal government.This study was approved by the Shanghai Tenth People's Hospital Institutional Review Board and was conducted under financial support from the Shanghai municipal government (grant ID: 2013ZYJB0902 and 15GWZK1002). The preliminary sample size is expected to be 3000-4000 participants.", 'detailedDescription': 'The Northern Shanghai Study is an ongoing prospective community-based study. After enrolment, clinical examination,anthropometric measurement and a questionnaire will be administered to each participant at baseline and patients will be followed up every six months. Our tests and examinations include: blood/urine sample and biochemical measurements, office blood pressure recording, carotid ultrasonograph, echocardiograph, pulse wave velocity, pulse wave analysis, 4-limb blood pressure recording, body mass index, etc. Baseline measurement will also include the assessments on target organ damages(TODs) and the conventional CV risk factors. In the follow-up, the incidence of CV events and mortality will be recorded. The Northern Shanghai Risk Score will be calculated, with considerations on CV risk factors and TODs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Northern Shanghai region has the largest population of elderly adults in Shanghai, with a total population of 1.57 million and an elderly proportion of over 19%. We use a computer-generated list of communities, and 10 communities were randomly selected for the first-phase enrolment. Other communities in the list will be randomly selected for the later enrolment. According to the inclusion and exclusion criteria, we invite all the eligible older people (over 55 years) to participate in this study. The recruitment strategies include: (1) posting study recruitment files in the neighbourhood committees and community hospitals; (2) according to the health file, community hospitals recruit the potential participants Open Accessby telephone; (3) hand out recruitment flyers directly to the potential participants.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 55 years or more\n2. informed consent should be signed voluntarily\n3. local residents from communities in northern Shanghai and available for long-term follow-up\n\nExclusion Criteria:\n\n1. was diagnosed with serious heart disease (NYHA≥IV) or end-stage renal disease (CKD ≥4 stage)\n2. suffered from cancer or his/her life expectancy is \\<5 years\n3. had stroke within 3 months\n4. is not willing to participate in the clinical study\n5. has to quit the trial due to other diseases\n6. violates the protocol or loses contact with the laboratory staff.'}, 'identificationModule': {'nctId': 'NCT03735251', 'acronym': 'ELITISM', 'briefTitle': 'Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study', 'orgStudyIdInfo': {'id': 'ELITISM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Left Ventricular Diastoic Dysfunction Classification', 'description': "normal diastole pattern：E/A\\>1，DT 160\\~220 ms，S/D \\>1，AR 0.22-0.32m/sec，E/e'\\< 8 diastolic dysfunction pattern Impaired relaxation pattern：E/A\\< 1，DT \\> 220 ms，S/D \\> 1，AR 0.21-0.28 m/sec，E/e'\\<10 Pseudo-normalization pattern：E/A\\> 1，DT 150\\~210 ms，S/D \\< 1，AR ≥0.35m/sec，E/e'≥ 10 Restrictive pattern：E/A ≥ 2，DT \\< 150 ms，S/D \\<1，AR ≥0.25m/sec，E/e'≥10", 'interventionNames': ['Other: Diuretic，Betaloc，antiplatelet drugs']}], 'interventions': [{'name': 'Diuretic，Betaloc，antiplatelet drugs', 'type': 'OTHER', 'description': 'According to international guidelines,we treated patinets who suffered from different disease', 'armGroupLabels': ['Left Ventricular Diastoic Dysfunction Classification']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ya-Wei Xu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Shanghai 10th People's Hospital", 'investigatorFullName': 'Ya-Wei Xu', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}