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Evaluation of Feasibility of Radial Access for Primary Angioplasty and to Assess it in High Risk Subgroups

Sponsor
Jubilee Mission Medical College and Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03488407
Collaborator
(none)
315
Enrollment
11.8
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Primary percutaneous coronary intervention is the preferred treatment for patients with ST-segment acute coronary syndrome. The radial access is an established approach, associated with a reduction in vascular access related complications after primary percutaneous coronary interventions. The purpose of this study is to examine the baseline characteristics, risk factors, procedural parameters and complications in patients with STEMI taken for primary angioplasty by radial access.

Data of all patients with acute STEMI with primary PCI through radial access is to be evaluated for baseline characteristics and procedural parameters and complications. Patients in the prospective study are followed up till discharge and any in-hospital complication noted.

This was a prospective, observational and descriptive study. Three hundred fifteen consecutive patients with an ST-segment elevation acute myocardial infarction (STEMI) treated with primary angioplasty by radial access, admitted between March 2016 and Feb 2017 were analyzed for their baseline characteristics, risk factors, and procedural parameters, complications and outcomes. High risk sub-groups analysis was also done. High risk groups includes patients with age >75yrs, cardiogenic shock, severe LV systolic dysfunction, acute left ventricular failure, high degree AV block, right ventricular infarction and low BMI. The study is conducted among patients with acute STEMI, considered for primary PCI through radial artery access at operator discretion.

This study analyzed the baseline characteristics of patients which includes clinical history, clinical examination, ECG, 2D ECHO, coronary angiogram to evaluate cardiovascular risk factors.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    315 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Study to Evaluate Feasibility of Routine Use of Radial Access for Primary Angioplasty and to Assess it in Subgroups With Unfavorable Characteristics
    Actual Study Start Date :
    Mar 5, 2016
    Actual Primary Completion Date :
    Feb 28, 2017
    Actual Study Completion Date :
    Feb 28, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of radial angioplasty success in whole cohort. [one year]

      Angioplasty success rate (by TIMI flow grade)

    2. Evaluation of in-hospital complication. [One year]

      Rate of local complications

    Secondary Outcome Measures

    1. High risk v/s non-high risk subgroup analysis [one year]

      Non- inferiority of radial angioplasty for high risk group were assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients presenting with STEMI and being considered for primary PCI through radial access between March 2016 and Feb 2017.
    Exclusion Criteria:

    • Patients with ACS other than STEMI

    • All primary PCI in STEMI through femoral access.

    • All radial elective PCI.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Jubilee Mission Medical College and Research Institute

    Investigators

    • Principal Investigator: Rajesh Sharma, MD, Jubilee Mission Medical College & Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Rajesh Sharma, Senior Resident, Jubilee Mission Medical College and Research Institute
    ClinicalTrials.gov Identifier:
    NCT03488407
    Other Study ID Numbers:
    • 2/16/IEC/JMMC&RI
    First Posted:
    Apr 5, 2018
    Last Update Posted:
    Apr 5, 2018
    Last Verified:
    Mar 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr Rajesh Sharma, Senior Resident, Jubilee Mission Medical College and Research Institute
    Primary angioplasty
    Radial access
    STEMI

    Study Results

    No Results Posted as of Apr 5, 2018