Cardiovascular DiseasesBF-PCINCT05728580
PCI in Beijing Friendship Hospital
An observational study of Cardiovascular Diseases and Percutaneous Coronary Intervention, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The goal of this study is to discover the potential risk factors related percutaneous coronary intervention. It aims to stratify the risk of PCI patients and discover the prognostic value of these risk fators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Percutaneous Coronary Intervention
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2017to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PCI accorrding to Inclusion and exclusion criteria.
Who may be able to join
- Age greater than or equal to 18 years at the time of admission to the hospital
- PCI patients with coronary heart disease: according to the criteria interpreted in the 2011 American Guidelines for Percutaneous Coronary Intervention. The successful diagnostic criteria of PCI: residual stenosis of the treated vessel<10% (preferably 0%), and the forward flow is TIMI grade 3, there is no dissection that affects the flow, no important side branch occlusion, no visible thrombus and peripheral embolism.
Who cannot join
- Patients who failed in PCI treatment;
- Current known inability to follow instructions or comply with follow-up procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Hongwei Li, M.D, 0086 10 63139780, lhw19656@sina.com
Bingbing Ke, M.D, 0086 10 63138299, 1017120710@qq.com
About this study
Official title: Risk Factor for Percutaneous Coronary Intervention in the Beijing Friendship Hospital
The goal of this study is to discover the potential risk factors related percutaneous coronary intervention. It aims to stratify the risk of PCI patients and discover the prognostic value of these risk fators.
Read the detailed description
Coronary heart disease is the main cause of death worldwide. Ischemic heart disease is the most common cause of death. Percutaneous coronary intervention (PCI) is a very effective treatment for coronary heart disease, which can alleviate myocardial ischemia and reduce the mortality of patients with acute myocardial infarction. It is an important measure to treat coronary heart disease at present. However, the study found that the incidence of major adverse cardiac and cerebrovascular event (MACCE) after PCI was more than 10%, which could reach 20-30% in elderly patients. Therefore, the purpose of this study is to investigate the risk factors related to PCI and to intervene or change the treatment strategy as early as possible. Risk stratification was performed in these patients for improving the quality of life of patients, reducing medical costs, and improving the life expectancy of patients. Patients with PCI in Beijing friendship hospital are enrolled.The primary outcome is MACCE and all-cause mortality.
- Keywords
- coronary heart disease
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
defined as a composite of all cause mortality, any myocardial infarction (MI), any revascularization, stroke, and heart failure hospitalization
Measured: These data is collected during follow-up for 5 years after discharge
All-cause mortality
whether recidivation happened,whether other related disease happened
Measured: These data is collected during follow-up for 5 years after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start31 Dec 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongwei Li, Dr, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728580
- Sponsor's protocol ID
- BF-PCI
- Acronym
- BF-PCI
- Status last verified
- Dec 2023
- First submitted
- 6 Feb 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factor for Percutaneous Coronary Intervention in the Beijing Friendship Hospital
- ClinicalTrials.gov ID
- NCT05728580
- Acronym / sponsor ID
- BF-PCI / BF-PCI
- Keywords
- coronary heart disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Feb 2023 (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 goal of this study is to discover the potential risk factors related percutaneous coronary intervention. It aims to stratify the risk of PCI patients and discover the prognostic value of these risk fators.
Detailed description
Coronary heart disease is the main cause of death worldwide. Ischemic heart disease is the most common cause of death. Percutaneous coronary intervention (PCI) is a very effective treatment for coronary heart disease, which can alleviate myocardial ischemia and reduce the mortality of patients with acute myocardial infarction. It is an important measure to treat coronary heart disease at present. However, the study found that the incidence of major adverse cardiac and cerebrovascular event (MACCE) after PCI was more than 10%, which could reach 20-30% in elderly patients. Therefore, the purpose of this study is to investigate the risk factors related to PCI and to intervene or change the treatment strategy as early as possible. Risk stratification was performed in these patients for improving the quality of life of patients, reducing medical costs, and improving the life expectancy of patients. Patients with PCI in Beijing friendship hospital are enrolled.The primary outcome is MACCE and all-cause mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PCI accorrding to Inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years at the time of admission to the hospital
- PCI patients with coronary heart disease: according to the criteria interpreted in the 2011 American Guidelines for Percutaneous Coronary Intervention. The successful diagnostic criteria of PCI: residual stenosis of the treated vessel<10% (preferably 0%), and the forward flow is TIMI grade 3, there is no dissection that affects the flow, no important side branch occlusion, no visible thrombus and peripheral embolism.
Key exclusion criteria (2 listed)
- Patients who failed in PCI treatment;
- Current known inability to follow instructions or comply with follow-up procedures.
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
MACCE
Time frame: These data is collected during follow-up for 5 years after discharge
defined as a composite of all cause mortality, any myocardial infarction (MI), any revascularization, stroke, and heart failure hospitalization
All-cause mortality
Time frame: These data is collected during follow-up for 5 years after discharge
whether recidivation happened,whether other related disease happened
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- 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.
Hongwei Li, Dr study director
Beijing Friendship Hospital
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 Diseases and Percutaneous Coronary Intervention, 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingbing Ke, Dr (15510286857, 1017120710@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: These data is collected during follow-up for 5 years after discharge). 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?
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 Mar 2024.