Acute Coronary SyndromeNCT04044066
Biomarker-based Prognostic Assessment
An observational study of Acute Coronary Syndrome and Stable Angina, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. Improvement in biomarker, imaging research have led to new predictors for the prognosis, which may have great clinical value in the current era of personalized medicine. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome, Stable Angina
- What is being tested?
- Plasma biomarker
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2017to 31 Dec 2020
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: In this prospective, multicenter registry study, we will consecutively enroll eligible patients according to the pre-specified inclusion and exclusion criteria in 6 tertiary hospitals in China. Patients meeting all eligibility criteria will be tracked and their hospitalization data will be collected including baseline clinical and demographic data, risk factors, blood drawn and storage, lab testing results, angiographic and procedural data (if appropriate), medication and adverse events. Clinical follow-up visits will be sheduled at 30 days, 6 months and 12 months after discharge by telephone contact. Follow-up data will be collected and assessment for death (cardiac, non-cardiac), myocardial infarction, stroke, revascularization or bleeding events will be conducted.
Who may be able to join
- Hospitalized patients with the diagnosis of any type of coronary artery disease (stable angina, unstable angina, non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)
- Age ≥18 years of age and <85 years of age
- Patient or guardian provided informed written consent
Who cannot join
- Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al)
- Patient with non-cardiac co-morbidities with life expectancy less than 12 months
- Patients unwilling or unable to comply with all clinical follow-up schedules at 30 days, 6 months and 12 months after discharge
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yuguo Chen, MD,PhD, +8618678812777, chen919085@126.com
About this study
Official title: BIomarker-based Prognostic Assessment for Patients With Stable Angina and Acute Coronary Syndromes (BIPass)
Coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. Improvement in biomarker, imaging research have led to new predictors for the prognosis, which may have great clinical value in the current era of personalized medicine. However, there is no available biomarker-based prediction rule for risk assessment of adverse events in patients with stable angina and acute coronary disease. Therefore, we aim to develop and validate a new biomarker-based risk model to improve the prognostication of adverse events (e.g. ischemic and bleeding events ) in the patient population.
Read the detailed description
Patients enrolled in Qilu Hospital of Shandong University (Jinan, China), Chinese PLA General Hospital Hospital (Beijing, China) and Peking University First Hospital (Beijing, China) are designed as the development cohort to derive the risk prediction models of ischemic and bleeding events. Patients enrolled in Peking University Third Hospital ( Beijing, China) Zibo Central hospital (Zibo, China) are designed as the independent validation cohort.
- Conditions
- Acute Coronary Syndrome, Stable Angina
- Being tested
- Plasma biomarker
- Medical subject headings
- Acute Coronary Syndrome, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma biomarkerBiological
New emerging plasma biomarkers carrying prognositic information
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events
a composite of cardiac death, myocardial infarction or stroke
Measured: 12 months
Major bleeding
BARC 3 or more bleeding
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 posted2 Aug 2019
- Study start9 Nov 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Chinese PLA General Hospital, Peking University First Hospital, Central Hospital of Zibo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044066
- Sponsor's protocol ID
- 20172020
- Status last verified
- Jul 2020
- First submitted
- 1 Aug 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma Y, Liu S, Liu Z, Zhang J, Song D, Lv J, Chen J, Chen G, Zheng W, Ma J, Pang J, Wu S, Xu F, Qian J, Wang J, Zhang T, Chen Y. Association of admission serum potassium levels with mortality according to renal function in coronary artery disease: a prospective cohort study. Eur J Med Res. 2026 Mar 6. doi: 10.1186/s40001-026-04140-2. Online ahead of print.
PubMed 41792782Wang J, Zhang T, Xu F, Gao W, Chen M, Zhu H, Xu J, Yin X, Pang J, Zhang S, Wei M, Chen J, Liu Y, Yu X, Chew DP, Chen Y. GDF-15 at admission predicts cardiovascular death, heart failure, and bleeding outcomes in patients with CAD. ESC Heart Fail. 2023 Oct;10(5):3123-3132. doi: 10.1002/ehf2.14484. Epub 2023 Aug 24.
PubMed 37620152
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIomarker-based Prognostic Assessment for Patients With Stable Angina and Acute Coronary Syndromes (BIPass)
- ClinicalTrials.gov ID
- NCT04044066
- Acronym / sponsor ID
- 20172020
- Conditions
- Acute Coronary Syndrome, Stable Angina
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Chinese PLA General Hospital, Peking University First Hospital, Central Hospital of Zibo
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Aug 2019 (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.
Coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. Improvement in biomarker, imaging research have led to new predictors for the prognosis, which may have great clinical value in the current era of personalized medicine. However, there is no available biomarker-based prediction rule for risk assessment of adverse events in patients with stable angina and acute coronary disease. Therefore, we aim to develop and validate a new biomarker-based risk model to improve the prognostication of adverse events (e.g. ischemic and bleeding events ) in the patient population.
Detailed description
Patients enrolled in Qilu Hospital of Shandong University (Jinan, China), Chinese PLA General Hospital Hospital (Beijing, China) and Peking University First Hospital (Beijing, China) are designed as the development cohort to derive the risk prediction models of ischemic and bleeding events. Patients enrolled in Peking University Third Hospital ( Beijing, China) Zibo Central hospital (Zibo, China) are designed as the independent validation cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this prospective, multicenter registry study, we will consecutively enroll eligible patients according to the pre-specified inclusion and exclusion criteria in 6 tertiary hospitals in China. Patients meeting all eligibility criteria will be tracked and their hospitalization data will be collected including baseline clinical and demographic data, risk factors, blood drawn and storage, lab testing results, angiographic and procedural data (if appropriate), medication and adverse events. Clinical follow-up visits will be sheduled at 30 days, 6 months and 12 months after discharge by telephone contact. Follow-up data will be collected and assessment for death (cardiac, non-cardiac), myocardial infarction, stroke, revascularization or bleeding events will be conducted.
Key inclusion criteria (3 listed)
- Hospitalized patients with the diagnosis of any type of coronary artery disease (stable angina, unstable angina, non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)
- Age ≥18 years of age and <85 years of age
- Patient or guardian provided informed written consent
Key exclusion criteria (3 listed)
- Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al)
- Patient with non-cardiac co-morbidities with life expectancy less than 12 months
- Patients unwilling or unable to comply with all clinical follow-up schedules at 30 days, 6 months and 12 months after discharge
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 |
|---|---|---|
| Plasma biomarkerNew emerging plasma biomarkers carrying prognositic information | Biological | – |
Primary outcome
Major Adverse Cardiac Events
Time frame: 12 months
a composite of cardiac death, myocardial infarction or stroke
Major bleeding
Time frame: 12 months
BARC 3 or more bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 41792782Ma Y, Liu S, Liu Z, Zhang J, Song D, Lv J, Chen J, Chen G, Zheng W, Ma J, Pang J, Wu S, Xu F, Qian J, Wang J, Zhang T, Chen Y. Association of admission serum potassium levels with mortality according to renal function in coronary artery disease: a prospective cohort study. Eur J Med Res. 2026 Mar 6. doi: 10.1186/s40001-026-04140-2. Online ahead of print.
- Derived from this study: PubMed 37620152Wang J, Zhang T, Xu F, Gao W, Chen M, Zhu H, Xu J, Yin X, Pang J, Zhang S, Wei M, Chen J, Liu Y, Yu X, Chew DP, Chen Y. GDF-15 at admission predicts cardiovascular death, heart failure, and bleeding outcomes in patients with CAD. ESC Heart Fail. 2023 Oct;10(5):3123-3132. doi: 10.1002/ehf2.14484. Epub 2023 Aug 24.
- Individual participant dataSharing planned: Undecided
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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 Acute Coronary Syndrome and Stable Angina, run by Qilu Hospital of Shandong 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 3 inclusion and 3 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 7 Jul 2020. 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?
Contact Yuguo Chen, MD,PhD (+8618678812777, chen919085@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04044066, which also lists 2 linked publications.
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 7 Jul 2020.