Cardiovascular DiseaseNCT04460131
Soluble ST2 and Cardiovascular Outcome
An observational study of Cardiovascular Disease, run by Nanjing Medical University at 1 site in China.
Trial summary
Cardiac surgery induces hemodynamic stress on the myocardium, and this process can be associated with significant cardiovascular morbidity and mortality. Soluble suppression of tumorigenicity 2 (sST2) is biomarker of myocardial remodeling and fibrosis; however, little is known regarding their potential association… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- soluble ST2
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2025
- 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
- Adult, Older adult
Study population: Consecutive adults patients with heart disease who underwent cardiac surgery were included.
Who may be able to join
- age ≥ 18 years
- Congenital heart disease requiring surgery
- Valvular heart disease requiring surgery
- Arrhythmia requiring surgery
- Aortic dissection requiring surgery
- Coronary heart disease requiring surgery
Who cannot join
- age <18 years
- pregnancy
- severe renal dysfunction (creatinine >200µmol/L)
- not capable of understanding or signing informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, 210029
Hong Liu, MD, 188012181613, dr.hongliu@foxmail.com
About this study
Official title: Association Between Soluble ST2 and Cardiovascular Outcome After Cardiovascular Surgery
Cardiac surgery induces hemodynamic stress on the myocardium, and this process can be associated with significant cardiovascular morbidity and mortality. Soluble suppression of tumorigenicity 2 (sST2) is biomarker of myocardial remodeling and fibrosis; however, little is known regarding their potential association with cardiovascular events. This study aimed to investigate the release of sST2 and its association with cardiovascular events undergoing cardiac surgery.
- Conditions
- Cardiovascular Disease
- Being tested
- soluble ST2
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soluble ST2Diagnostic test
Serum sST2 was measured on a monoclonal electrochemiluminescence immunoassay. Samples were exposed to two freeze cycles before analysed. Samples were exposed to two thawfreeze cycles before analysed.
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Number of participants death of 30 days after surgery
Measured: 30 days after surgery
Secondary outcomes (1)
Heart failure
requiring initiation or change in heart failure medication or requiring hospitalisation
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Yong-feng Shao, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460131
- Sponsor's protocol ID
- sST2-2019
- Status last verified
- Apr 2022
- First submitted
- 2 Jul 2020
- Last updated
- 25 Apr 2022
- 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Soluble ST2 and Cardiovascular Outcome After Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT04460131
- Acronym / sponsor ID
- sST2-2019
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jul 2020 (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.
Cardiac surgery induces hemodynamic stress on the myocardium, and this process can be associated with significant cardiovascular morbidity and mortality. Soluble suppression of tumorigenicity 2 (sST2) is biomarker of myocardial remodeling and fibrosis; however, little is known regarding their potential association with cardiovascular events. This study aimed to investigate the release of sST2 and its association with cardiovascular events undergoing cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive adults patients with heart disease who underwent cardiac surgery were included.
Key inclusion criteria (6 listed)
- age ≥ 18 years
- Congenital heart disease requiring surgery
- Valvular heart disease requiring surgery
- Arrhythmia requiring surgery
- Aortic dissection requiring surgery
Key exclusion criteria (4 listed)
- age <18 years
- pregnancy
- severe renal dysfunction (creatinine >200µmol/L)
- not capable of understanding or signing informed consent.
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 |
|---|---|---|
| soluble ST2Serum sST2 was measured on a monoclonal electrochemiluminescence immunoassay. Samples were exposed to two freeze cycles before analysed. Samples were exposed to two thawfreeze cycles before analysed. | Diagnostic test | – |
Primary outcome
All-cause mortality
Time frame: 30 days after surgery
Number of participants death of 30 days after surgery
1 secondary outcome
Heart failure
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
Related trials for Cardiovascular Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
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.
Yong-feng Shao study chair
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 Cardiovascular Disease, run by 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 6 inclusion and 4 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 25 Apr 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?
Contact Yong-feng Shao (+8618801281613, yfshaojph@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days after surgery). 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 25 Apr 2022.