Coronary Artery DiseaseNCT05270330
Plaque Stability and Metabolomics in Coronary Heart Disease
An observational study of Coronary Artery Disease, run by Shaanxi Provincial People's Hospital at 1 site in China.
Trial summary
At present, the investigators don't know the relationship between plaque stability and the metabonomics changes. In the present study, investigators will evaluate the plaque stability by intravascular unltrasound in stable coronary heart patients, and metabonomics was also assessed by high throughput sequencing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- This is an observational study, we don't have any interventions.
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Jul 2024
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with stable coronary heart disease and assessed for plaque stability by IVUS will be recruited in our study.
Who may be able to join
- Patients who diagnosed with stable coronary heart disease and evaluated for plaque stability by IVUS will be recruited.
Who cannot join
- renal insufficiency with serum creatinine > 20 mg/L;
- regnant/lactating women, or the women receive hormone replacement therapy in premenopausal or postmenopausal;
- patients have a history of abusing alcohol or other drugs in the past two years, active hepatitis, cirrhosis;
- endocrine abnormalities without therapy (diabetic ketoacidosis, thyroid disease, etc.);
- The body's inflammatory disease, rheumatoid arthritis, osteoarthritis, ulcerative bowel disease, systemic lupus erythematosus (sle), etc.), myositis/myopathy, cancer;
- Dilated cardiomyopathy, valvular heart disease, persistent atrial fibrillation;
- patients recently injured;（8）Other researchers don't agree to join this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710061
Na Zhu, M.D, 86-29-85251331 ext. 3194, axemaxme2@sina.com
About this study
Official title: The Relationship Between Plaque Stability Evaluated by IVUS and Metabolomics in Stable Coronary Heart Disease Patients
At present, the investigators don't know the relationship between plaque stability and the metabonomics changes. In the present study, investigators will evaluate the plaque stability by intravascular unltrasound in stable coronary heart patients, and metabonomics was also assessed by high throughput sequencing. Statistic analysis were carried out to analyze the correlation between plaque stability and metabonomics changes among these study patients.
- Conditions
- Coronary Artery Disease
- Being tested
- This is an observational study, we don't have any interventions.
- Keywords
- plaque stability, metabonomics
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study, we don't have any interventions.Other
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque stability
The investigators will use the intravascular ultrasound to assess the coronary plaque stability of the patients with coronary heart disease.
Measured: 07/01/2021-07/31/2024
Secondary outcomes (1)
Metabonomics
Serum or plasma will be collected by the investigators and high-throughput sequencing will be used to assess the metabonomics of patients with coronary heart disease.
Measured: 07/01/2021-07/31/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Jul 2021
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhongwei, Shaanxi Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270330
- Sponsor's protocol ID
- 2021BJ-02
- Status last verified
- Mar 2022
- First submitted
- 22 Jan 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Plaque Stability Evaluated by IVUS and Metabolomics in Stable Coronary Heart Disease Patients
- ClinicalTrials.gov ID
- NCT05270330
- Acronym / sponsor ID
- 2021BJ-02
- Conditions
- Coronary Artery Disease
- Keywords
- plaque stability, metabonomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shaanxi Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 8 Mar 2022 (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.
At present, the investigators don't know the relationship between plaque stability and the metabonomics changes. In the present study, investigators will evaluate the plaque stability by intravascular unltrasound in stable coronary heart patients, and metabonomics was also assessed by high throughput sequencing. Statistic analysis were carried out to analyze the correlation between plaque stability and metabonomics changes among these study patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with stable coronary heart disease and assessed for plaque stability by IVUS will be recruited in our study.
Key inclusion criteria (1 listed)
- Patients who diagnosed with stable coronary heart disease and evaluated for plaque stability by IVUS will be recruited.
Key exclusion criteria (7 listed)
- renal insufficiency with serum creatinine > 20 mg/L;
- regnant/lactating women, or the women receive hormone replacement therapy in premenopausal or postmenopausal;
- patients have a history of abusing alcohol or other drugs in the past two years, active hepatitis, cirrhosis;
- endocrine abnormalities without therapy (diabetic ketoacidosis, thyroid disease, etc.);
- The body's inflammatory disease, rheumatoid arthritis, osteoarthritis, ulcerative bowel disease, systemic lupus erythematosus (sle), etc.), myositis/myopathy, cancer;
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 |
|---|---|---|
| This is an observational study, we don't have any interventions.No intervention | Other | – |
Primary outcome
Plaque stability
Time frame: 07/01/2021-07/31/2024
The investigators will use the intravascular ultrasound to assess the coronary plaque stability of the patients with coronary heart disease.
1 secondary outcome
Metabonomics
Time frame: 07/01/2021-07/31/2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shaanxi Provincial People's Hospital at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque stability (time frame: 07/01/2021-07/31/2024). 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 8 Mar 2022.