Coronary Artery DiseasePREDICTION-NJNCT05015270
Correlation of Biomarkers With the Presence and Severity of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The development of coronary artery disease is multifactorial. Peripheral blood biomarkers paly an important role in the prediction of coronary artery disease. However, the identification of those biomarkers and their correlation with the presence and severity of coronary artery disease are unclear. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Medications or percutaneous coronary intervention
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2021to 30 Dec 2021
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In geneal, the traditional risk factors for coronary artery disease (including age, sex, hypertension, diabetes, dyslipidemia, peripheral artery disease, smoker, fat, etc.) will be comparble between three groups (case-control).
Who may be able to join
- For Pilot study, both health and patients with at least one epicardial coronary artery disease are included
- For both Training group and Validation group, patients must have at least one epicardial coronary artery disease
- Left ventricular ejection fraction > 30%
- Stable or unstable angina
- Myocardial infarction older than 1 month
- No active inflammation
Show all 9Show fewer
- No scheduled non-cardiac surgery within 12 months
- eGFR > 30 ml/min/m2
- Patients agree to participate in this study
Who cannot join
- Severe liver dysfunction
- Blood platelet count <100 x 109/L
- Cancer
- On dialysis
- Pulmonary hypertension (defined as mean pulmonary arterial pressure > 25 mmHg and pulmonary vessel resistance > 3.0 Woods Unit)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Peripheral Blood Biomarkers for Prediction of Coronary Artery Disease Confirmed by Coronary Angiography
The development of coronary artery disease is multifactorial. Peripheral blood biomarkers paly an important role in the prediction of coronary artery disease. However, the identification of those biomarkers and their correlation with the presence and severity of coronary artery disease are unclear. The present study aims to identify the differentially expressed biomarkers from peripheral blood between normal population and patients with different disease burden confirmed by coronary angiography, and to analyze the correlation of those biomarkers with the severity of coronary artery disease. Finally, the prediction of biomarkers for clinical events.
Read the detailed description
This study includes three parts:
- Part 1 (Pilot analysis): 30 normal people and 30 patients with at least one epicardial coronary artery disease confirmed by angiography will be included. 10 ml peripheral blood from arterial sheath (just before angiography) will be collected in each subject. Proteomics analyses are performed in order to obtain the differentially expressed proteins (coded by Proteins 1-x.
- Part 2 (Training group): Differentially expressed Proteins 1-x are measured and compared between patients with diameter stenosis <70% (n=100) vs. with diameter stenosis ≥ 70%(n=100), respectively. Finally, Proteins 1-y from Proteins 1-x will be identified. Subgroups stratified by single-, double-, and triple-vessel disease will be performed.
- Part 3 (Validation group): The difference in blood concentration of Proteins 1-y between patients with different disease burden will be further analyzed: patients with diameter stenosis <70% (n=200) vs. diameter stenosis ≥70% (n=200), respectively. Subgroups stratified by single-, double-, and triple-vessel disease will be performed.
- Conditions
- Coronary Artery Disease
- Being tested
- Medications or percutaneous coronary intervention
- Keywords
- Biomarkers, Coronary artery disease, Disease burden, Clinical events
- 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.
Medications or percutaneous coronary interventionDiagnostic test
Also called Percutaneous coronary intervention
In this study, we will for the first analyze the correlation of proteins concentration with coronary artery disease burden. Next, the prediction of proteins for one-year clinical events will be further analyzed
| Study group | Role | What they receive |
|---|---|---|
| Less disease group | Patients with coronary artery diameter stenosis <70% confirmed by coronary angiography;
Patients will be treated using guideline recommended medications or percutaneous coronary intervention at physician's discretion Receives: Diagnostic Test: Medications or percutaneous coronary intervention | |
| Severe disease group | Patients with coronary artery stenosis ≥70% confirmed by coronary angiography;
Patients will be treated using guideline recommended medications or percutaneous coronary intervention at physician's discretion Receives: Diagnostic Test: Medications or percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of biomarkers with coronary artery disease burden
We will analyze the differential level of proteins in peripheral blood between three groups. As a result, the correlation between biomarkers with disease burden will analyzed.
Measured: 12 months
Secondary outcomes (1)
Clinical events
Clinical events are a composite of cardiac death, myocardial infarction, revascularization, and stroke at one-year since coronary angiography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start21 Jul 2021
- Primary completion27 Dec 2021
- Study completion30 Dec 2021
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.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shao-Liang M Chen, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015270
- Sponsor's protocol ID
- NMU20211033
- Acronym
- PREDICTION-NJ
- Status last verified
- Mar 2022
- First submitted
- 18 Aug 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No share IPD with others
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Peripheral Blood Biomarkers for Prediction of Coronary Artery Disease Confirmed by Coronary Angiography
- ClinicalTrials.gov ID
- NCT05015270
- Acronym / sponsor ID
- PREDICTION-NJ / NMU20211033
- Conditions
- Coronary Artery Disease
- Keywords
- Biomarkers, Coronary artery disease, Disease burden, Clinical events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 20 Aug 2021 (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.
The development of coronary artery disease is multifactorial. Peripheral blood biomarkers paly an important role in the prediction of coronary artery disease. However, the identification of those biomarkers and their correlation with the presence and severity of coronary artery disease are unclear. The present study aims to identify the differentially expressed biomarkers from peripheral blood between normal population and patients with different disease burden confirmed by coronary angiography, and to analyze the correlation of those biomarkers with the severity of coronary artery disease. Finally, the prediction of biomarkers for clinical events.
Detailed description
This study includes three parts:
- Part 1 (Pilot analysis): 30 normal people and 30 patients with at least one epicardial coronary artery disease confirmed by angiography will be included. 10 ml peripheral blood from arterial sheath (just before angiography) will be collected in each subject. Proteomics analyses are performed in order to obtain the differentially expressed proteins (coded by Proteins 1-x.
- Part 2 (Training group): Differentially expressed Proteins 1-x are measured and compared between patients with diameter stenosis <70% (n=100) vs. with diameter stenosis ≥ 70%(n=100), respectively. Finally, Proteins 1-y from Proteins 1-x will be identified. Subgroups stratified by single-, double-, and triple-vessel disease will be performed.
- Part 3 (Validation group): The difference in blood concentration of Proteins 1-y between patients with different disease burden will be further analyzed: patients with diameter stenosis <70% (n=200) vs. diameter stenosis ≥70% (n=200), respectively. Subgroups stratified by single-, double-, and triple-vessel disease will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less disease group | – | Diagnostic Test: Medications or percutaneous coronary interventionPatients with coronary artery diameter stenosis <70% confirmed by coronary angiography; Patients will be treated using guideline recommended medications or percutaneous coronary intervention at physician's discretion |
| Severe disease group | – | Diagnostic Test: Medications or percutaneous coronary interventionPatients with coronary artery stenosis ≥70% confirmed by coronary angiography; Patients will be treated using guideline recommended medications or percutaneous coronary intervention at physician's discretion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In geneal, the traditional risk factors for coronary artery disease (including age, sex, hypertension, diabetes, dyslipidemia, peripheral artery disease, smoker, fat, etc.) will be comparble between three groups (case-control).
Key inclusion criteria (9 listed)
- For Pilot study, both health and patients with at least one epicardial coronary artery disease are included
- For both Training group and Validation group, patients must have at least one epicardial coronary artery disease
- Left ventricular ejection fraction > 30%
- Stable or unstable angina
- Myocardial infarction older than 1 month
Key exclusion criteria (5 listed)
- Severe liver dysfunction
- Blood platelet count <100 x 109/L
- Cancer
- On dialysis
- Pulmonary hypertension (defined as mean pulmonary arterial pressure > 25 mmHg and pulmonary vessel resistance > 3.0 Woods Unit)
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 |
|---|---|---|
| Medications or percutaneous coronary interventionAlso: Percutaneous coronary interventionIn this study, we will for the first analyze the correlation of proteins concentration with coronary artery disease burden. Next, the prediction of proteins for one-year clinical events will be further analyzed | Diagnostic test | Less disease group, Severe disease group |
Primary outcome
Correlation of biomarkers with coronary artery disease burden
Time frame: 12 months
We will analyze the differential level of proteins in peripheral blood between three groups. As a result, the correlation between biomarkers with disease burden will analyzed.
1 secondary outcome
Clinical events
Time frame: 12 months
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 29 Mar 2022.
- Individual participant dataSharing planned: No. No share IPD with others
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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.
Shao-Liang M Chen, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
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 Nanjing First Hospital, Nanjing Medical University 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 9 inclusion and 5 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 29 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?
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?
Correlation of biomarkers with coronary artery disease burden (time frame: 12 months). 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 29 Mar 2022.