BF-PCI: PCI in Beijing Friendship Hospital

Sponsor
Beijing Friendship Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05728580
Collaborator
(none)
10,000
1
120
83.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Risk Factor for Percutaneous Coronary Intervention in the Beijing Friendship Hospital
    Actual Study Start Date :
    Dec 31, 2017
    Actual Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2027

    Outcome Measures

    Primary Outcome Measures

    1. MACCE [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

    2. All-cause mortality [These data is collected during follow-up for 5 years after discharge]

      whether recidivation happened,whether other related disease happened

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050

    Sponsors and Collaborators

    • Beijing Friendship Hospital

    Investigators

    • Study Director: Hongwei Li, Dr, Beijing Friendship Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Friendship Hospital
    ClinicalTrials.gov Identifier:
    NCT05728580
    Other Study ID Numbers:
    • BF-PCI
    First Posted:
    Feb 15, 2023
    Last Update Posted:
    Feb 15, 2023
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Beijing Friendship Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2023