STEMINCT05368584
Relationship Between Level of GPCR Autoantibodies and Cardiac Structure & Funtions Based on UCG and CMR
An observational study of STEMI, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study is a prospective cohort study，we want to observe the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI;and combined with different cardiovascular antibody levels and various indicators, evaluate the impact of ischemia-reperfusion injury and prognosis in STEMI… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2022to Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ① Patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent emergency PCI in Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University. ②In the Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University, coronary angiography showed negative coronary angiography in patients with non-coronary heart disease.
Who may be able to join
- STEMI patients meet the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2015)"; ②STMEI patients undergoing emergency PCI should undergo emergency PCI within 12 hours of onset at Beijing Friendship Hospital affiliated to Capital Medical University; ③ The selected patients were able to complete the MRI and STE examinations; ④ They agreed to be enrolled in the trial and signed the informed consent.
Who cannot join
- Past myocardial infarction or revascularization (PCI or CABG); ②Congestive heart failure LVEF<40%; ③Atrial fibrillation; ④Renal insufficiency (GFR<30 ml/min); disease; ⑥ rheumatic immune system disease; ⑦ malignant tumor; ⑧ claustrophobia; ⑨ contraindication to CMR;
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective cohort study，we want to observe the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI;and combined with different cardiovascular antibody levels and various indicators, evaluate the impact of ischemia-reperfusion injury and prognosis in STEMI patients after emergency PCI.
Read the detailed description
This study mainly observed the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI by measuring autoantibodies; and the changes of autoantibodies in STEMI patients compared with coronary angiography-negative patients. At the same time, combined with different cardiovascular antibody levels and various indicators, the effect of ischemia-reperfusion injury and prognosis after emergency PCI in STEMI patients was evaluated. The correlation between autoantibody changes and imaging indicators in STEMI patients was evaluated by cardiac color Doppler ultrasound and CMR.
- Conditions
- STEMI
- Keywords
- STEMI, GPCR, PCI
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
β1-AA, β2-AA, α1-AA, M2-AA and AT1-AA OD values
About 10ml of venous blood was collected on the second day of admission, serum was separated, and the OD values of β1-AA, β2-AA, α1-AA, M2-AA and AT1-AA were detected by ELISA.
Measured: Admission Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start7 May 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Li, MD, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368584
- Sponsor's protocol ID
- BFH-autoantibodies and STEMI
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Level of GPCR Autoantibodies and Cardiac Structure & Funtions Based on UCG and CMR
- ClinicalTrials.gov ID
- NCT05368584
- Acronym / sponsor ID
- BFH-autoantibodies and STEMI
- Conditions
- STEMI
- Keywords
- STEMI, GPCR, PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 7 May 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 May 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.
This study is a prospective cohort study，we want to observe the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI;and combined with different cardiovascular antibody levels and various indicators, evaluate the impact of ischemia-reperfusion injury and prognosis in STEMI patients after emergency PCI.
Detailed description
This study mainly observed the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI by measuring autoantibodies; and the changes of autoantibodies in STEMI patients compared with coronary angiography-negative patients. At the same time, combined with different cardiovascular antibody levels and various indicators, the effect of ischemia-reperfusion injury and prognosis after emergency PCI in STEMI patients was evaluated. The correlation between autoantibody changes and imaging indicators in STEMI patients was evaluated by cardiac color Doppler ultrasound and CMR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ① Patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent emergency PCI in Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University. ②In the Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University, coronary angiography showed negative coronary angiography in patients with non-coronary heart disease.
Key inclusion criteria (1 listed)
- STEMI patients meet the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2015)"; ②STMEI patients undergoing emergency PCI should undergo emergency PCI within 12 hours of onset at Beijing Friendship Hospital affiliated to Capital Medical University; ③ The selected patients were able to complete the MRI and STE examinations; ④ They agreed to be enrolled in the trial and signed the informed consent.
Key exclusion criteria (1 listed)
- Past myocardial infarction or revascularization (PCI or CABG); ②Congestive heart failure LVEF<40%; ③Atrial fibrillation; ④Renal insufficiency (GFR<30 ml/min); disease; ⑥ rheumatic immune system disease; ⑦ malignant tumor; ⑧ claustrophobia; ⑨ contraindication to CMR;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
β1-AA, β2-AA, α1-AA, M2-AA and AT1-AA OD values
Time frame: Admission Baseline
About 10ml of venous blood was collected on the second day of admission, serum was separated, and the OD values of β1-AA, β2-AA, α1-AA, M2-AA and AT1-AA were detected by ELISA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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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.
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 STEMI, run by Beijing Friendship 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 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: status not confirmed, as of the sponsor's last update on 10 May 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?
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?
β1-AA, β2-AA, α1-AA, M2-AA and AT1-AA OD values (time frame: Admission Baseline). 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 10 May 2022.