Uric Acid SerumASSURENCT03616769
A Prospective Cohort Study of China Serum Uric Acid Levels
An observational study of Uric Acid Serum, run by Shanghai 10th People's Hospital.
Trial summary
Uric acid is the final breakdown product of purine degradation in humans. The association between high serum uric acid levels and arterial stiffness as well as endothelial dysfunction has been demonstrated in humans and uric acid has been suggested to be an important modulator of the inflammatory process. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Uric Acid Serum
- What is being tested?
- antiplatelet drugs ,statins ,antihypertensive drugs
- How many people
- 3,535 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2011to 10 Jun 2018
- How long will I take part?
- 6 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There were 3,535 participants from multi-central departments with multiple classical Framingham risk factors atherosclerosis, 76 of whom had missing follow-up data. Thus,the study sample actually comprised 3,047 valid participants whose age older than or equal to 35 years.All participants were followed up from November 2011 to June 2018. A total of hospitalized patients were consecutively enrolled from the cardiology department and under treatment because of cardiovascular diseases .
Who may be able to join
- age older than or equal to 35 years with multiple classical Framingham risk factors patients.
Who cannot join
- Severe congestive heart failure and Severe renal failure patients.Severe congestive heart failure was defined that above or equal to cardiac functional classify 3 formulated by New York Heart Association (NYHA). Severe renal failure was defined as an estimated glomerular filtration rate <60 ml/ min/1.73m2.
About this study
Official title: Relationship of Serum Uric Acid Levels With All Cause Mortality and Cardiovascular Mortality in Multiple Classical Framingham Risk Factors Patients After a Six-year Follow-up: a China Prospective Cohort Study
Uric acid is the final breakdown product of purine degradation in humans. The association between high serum uric acid levels and arterial stiffness as well as endothelial dysfunction has been demonstrated in humans and uric acid has been suggested to be an important modulator of the inflammatory process. But debates still existed for hyperuricemia and hypouricemia as an independent role,especially after controlling other traditional atherosclerotic risk.The aim of this study was, firstly, to verify the association between hyperuricemia and cardiovascular diseases,secondly,to assess whether hypouricemia was an independent risk factor impact for cardiovascular disea.
Read the detailed description
The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011. The eligible participants were followed up from November 2011 to June 2018 (mean follow-up months 68.71±11.35). During the followed-up time, 67 patients had missing data and 56 had no compliance. Thus, the study sample actually comprised 3,047 valid participants (1536 men, 1511 women) whose age older than or equal to 35 years (mean age 60.2±10.4 years) were followed up. A total of hospitalized patients were consecutively enrolled from cardiology department of Beijing and Shanghai. All subjects are under treatment because of cardiovascular diseases.
- Conditions
- Uric Acid Serum
- Being tested
- antiplatelet drugs ,statins ,antihypertensive drugs
- Keywords
- Uric Acid Serum; Prospective;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiplatelet drugs ,statins ,antihypertensive drugsDrug
According to the international guidelines, we treated patients who suffered from different disease.
| Study group | Role | What they receive |
|---|---|---|
| quantiles of serum uric acid level | quantiles according to the patient's serum uric acid level Receives: Drug: antiplatelet drugs ,statins ,antihypertensive drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality and cardiovascular mortality
Cardiovascular events definitions: Hospitalized myocardial infarction was classified as definite or probable based on chest pain symptoms, cardiac enzyme levels, and electrocardiographic findings, or angioplasty28. Coronary heart disease was determined to be present if there was (1) electrocardiographic (ECG) evidence of a prior myocardial infarction, (2) prior coronary artery bypass surgery or angioplasty, (3) Coronary angiography show coronary heart disease, (4) have symptoms of angina and ECG revealed myocardial ischemia performance or laboratory tests showed cardiac enzymes increased and exclude other types of disease, (5) a self-reported history of a physician-diagnosed heart attack 29. CHD death was classified "definite" based on chest pain symptoms, hospital records, and medical history.
Measured: rom November 2011 to June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start20 Nov 2011
- Primary completion12 Mar 2013
- Study completion10 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uric Acid SerumStudies 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
- 3,535 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616769
- Sponsor's protocol ID
- ASSURE
- Other IDs
- 15GWZK1002
- Acronym
- ASSURE
- Status last verified
- Mar 2021
- First submitted
- 31 Jul 2018
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cang Y, Xu S, Zhang J, Ju J, Chen Z, Wang K, Li J, Xu Y. Serum Uric Acid Revealed a U-Shaped Relationship With All-Cause Mortality and Cardiovascular Mortality in High Atherosclerosis Risk Patients: The ASSURE Study. Front Cardiovasc Med. 2021 May 24;8:641513. doi: 10.3389/fcvm.2021.641513. eCollection 2021.
PubMed 34109223
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Serum Uric Acid Levels With All Cause Mortality and Cardiovascular Mortality in Multiple Classical Framingham Risk Factors Patients After a Six-year Follow-up: a China Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03616769
- Acronym / sponsor ID
- ASSURE / ASSURE
- Conditions
- Uric Acid Serum
- Keywords
- Uric Acid Serum; Prospective;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,535 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 20 Nov 2011 (actual)
- Primary completion
- 12 Mar 2013 (actual)
- Study completion
- 10 Jun 2018 (actual)
- First posted
- 6 Aug 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.
Uric acid is the final breakdown product of purine degradation in humans. The association between high serum uric acid levels and arterial stiffness as well as endothelial dysfunction has been demonstrated in humans and uric acid has been suggested to be an important modulator of the inflammatory process. But debates still existed for hyperuricemia and hypouricemia as an independent role,especially after controlling other traditional atherosclerotic risk.The aim of this study was, firstly, to verify the association between hyperuricemia and cardiovascular diseases,secondly,to assess whether hypouricemia was an independent risk factor impact for cardiovascular disea.
Detailed description
The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011. The eligible participants were followed up from November 2011 to June 2018 (mean follow-up months 68.71±11.35). During the followed-up time, 67 patients had missing data and 56 had no compliance. Thus, the study sample actually comprised 3,047 valid participants (1536 men, 1511 women) whose age older than or equal to 35 years (mean age 60.2±10.4 years) were followed up. A total of hospitalized patients were consecutively enrolled from cardiology department of Beijing and Shanghai. All subjects are under treatment because of cardiovascular diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quantiles of serum uric acid level | – | Drug: antiplatelet drugs ,statins ,antihypertensive drugsquantiles according to the patient's serum uric acid level |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There were 3,535 participants from multi-central departments with multiple classical Framingham risk factors atherosclerosis, 76 of whom had missing follow-up data. Thus,the study sample actually comprised 3,047 valid participants whose age older than or equal to 35 years.All participants were followed up from November 2011 to June 2018. A total of hospitalized patients were consecutively enrolled from the cardiology department and under treatment because of cardiovascular diseases .
Key inclusion criteria (1 listed)
- age older than or equal to 35 years with multiple classical Framingham risk factors patients.
Key exclusion criteria (1 listed)
- Severe congestive heart failure and Severe renal failure patients.Severe congestive heart failure was defined that above or equal to cardiac functional classify 3 formulated by New York Heart Association (NYHA). Severe renal failure was defined as an estimated glomerular filtration rate <60 ml/ min/1.73m2.
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 |
|---|---|---|
| antiplatelet drugs ,statins ,antihypertensive drugsAccording to the international guidelines, we treated patients who suffered from different disease. | Drug | quantiles of serum uric acid level |
Primary outcome
all cause mortality and cardiovascular mortality
Time frame: rom November 2011 to June 2018
Cardiovascular events definitions: Hospitalized myocardial infarction was classified as definite or probable based on chest pain symptoms, cardiac enzyme levels, and electrocardiographic findings, or angioplasty28. Coronary heart disease was determined to be present if there was (1) electrocardiographic (ECG) evidence of a prior myocardial infarction, (2) prior coronary artery bypass surgery or angioplasty, (3) Coronary angiography show coronary heart disease, (4) have symptoms of angina and ECG revealed myocardial ischemia performance or laboratory tests showed cardiac enzymes increased and exclude other types of disease, (5) a self-reported history of a physician-diagnosed heart attack 29. CHD death was classified "definite" based on chest pain symptoms, hospital records, and medical history.
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 24 Mar 2021.
- Derived from this study: PubMed 34109223Cang Y, Xu S, Zhang J, Ju J, Chen Z, Wang K, Li J, Xu Y. Serum Uric Acid Revealed a U-Shaped Relationship With All-Cause Mortality and Cardiovascular Mortality in High Atherosclerosis Risk Patients: The ASSURE Study. Front Cardiovasc Med. 2021 May 24;8:641513. doi: 10.3389/fcvm.2021.641513. eCollection 2021.
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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. 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 Uric Acid Serum, run by Shanghai 10th People's Hospital.
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: finished, as of the sponsor's last update on 24 Mar 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?
all cause mortality and cardiovascular mortality (time frame: rom November 2011 to June 2018). 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 NCT03616769, which also lists 1 linked publication.
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 24 Mar 2021.