Left Ventricular Diastoic Dysfunction Cohort StudyELITISMNCT03735251
Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study
An observational study of Left Ventricular Diastoic Dysfunction Cohort Study, run by Ya-Wei Xu.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Diastoic Dysfunction Cohort Study
- What is being tested?
- Diuretic，Betaloc，antiplatelet drugs
- How many people
- 1,920 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2014to 10 Aug 2014
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- age 55 years or more
- informed consent should be signed voluntarily
- local residents from communities in northern Shanghai and available for long-term follow-up
Who cannot join
- was diagnosed with serious heart disease (NYHA≥IV) or end-stage renal disease (CKD ≥4 stage)
- suffered from cancer or his/her life expectancy is <5 years
- had stroke within 3 months
- is not willing to participate in the clinical study
- has to quit the trial due to other diseases
- violates the protocol or loses contact with the laboratory staff.
About this study
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.
Read the detailed description
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.
- Being tested
- Diuretic，Betaloc，antiplatelet drugs
- Keywords
- Left Ventricular Diastoic Dysfunction Cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diuretic，Betaloc，antiplatelet drugsOther
According to international guidelines,we treated patinets who suffered from different disease
| Study group | Role | What they receive |
|---|---|---|
| Left Ventricular Diastoic Dysfunction Classification | 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 Receives: Other: Diuretic，Betaloc，antiplatelet drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular diastolic dysfunction
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.
left 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
Measured: From July 2014 to August 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start10 Jul 2014
- Primary completion10 Jul 2014
- Study completion10 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Diastoic Dysfunction Cohort StudyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,920 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ya-Wei Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735251
- Sponsor's protocol ID
- ELITISM
- Acronym
- ELITISM
- Status last verified
- Jul 2014
- First submitted
- 7 Nov 2018
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study
- ClinicalTrials.gov ID
- NCT03735251
- Acronym / sponsor ID
- ELITISM / ELITISM
- Keywords
- Left Ventricular Diastoic Dysfunction Cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,920 participants (actual)
- Lead sponsor
- Ya-Wei XuUniversity, hospital or other
- Study start
- 10 Jul 2014 (actual)
- Primary completion
- 10 Jul 2014 (actual)
- Study completion
- 10 Aug 2014 (actual)
- First posted
- 8 Nov 2018 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left Ventricular Diastoic Dysfunction Classification | – | Other: Diuretic，Betaloc，antiplatelet drugsnormal 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- age 55 years or more
- informed consent should be signed voluntarily
- local residents from communities in northern Shanghai and available for long-term follow-up
Key exclusion criteria (6 listed)
- was diagnosed with serious heart disease (NYHA≥IV) or end-stage renal disease (CKD ≥4 stage)
- suffered from cancer or his/her life expectancy is <5 years
- had stroke within 3 months
- is not willing to participate in the clinical study
- has to quit the trial due to other diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diuretic，Betaloc，antiplatelet drugsAccording to international guidelines,we treated patinets who suffered from different disease | Other | Left Ventricular Diastoic Dysfunction Classification |
Primary outcome
left ventricular diastolic dysfunction
Time frame: From July 2014 to August 2019
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. left 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Diastoic Dysfunction Cohort Study, run by Ya-Wei Xu.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular diastolic dysfunction (time frame: From July 2014 to August 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2021.