- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05728580
PCI in Beijing Friendship Hospital (BF-PCI)
March 21, 2024 updated by: Beijing Friendship Hospital
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.
Study Overview
Status
Recruiting
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 Type
Observational
Enrollment (Estimated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bingbing Ke, Dr
- Phone Number: 15510286857
- Email: 1017120710@qq.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Recruiting
- Beijing Friendship Hospital, Capital Medical University
-
Contact:
- Hongwei Li, M.D
- Phone Number: 0086 10 63139780
- Email: lhw19656@sina.com
-
Contact:
- Bingbing Ke, M.D
- Phone Number: 0086 10 63138299
- Email: 1017120710@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with PCI accorrding to Inclusion and exclusion criteria.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who failed in PCI treatment;
- Current known inability to follow instructions or comply with follow-up procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
These data is collected during follow-up for 5 years after discharge
|
|
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
|
These data is collected during follow-up for 5 years after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hongwei Li, Dr, Beijing Friendship Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 31, 2017
Primary Completion (Actual)
December 31, 2022
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
February 6, 2023
First Submitted That Met QC Criteria
February 6, 2023
First Posted (Actual)
February 15, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BF-PCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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