Skip to main content
OpenTrials
Completed

NCT Number: NCT03488407

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluation of radial angioplasty success in whole cohort.

    Time frame: one year

    Angioplasty success rate (by TIMI flow grade)

  2. Evaluation of in-hospital complication.

    Time frame: One year

    Rate of local complications

Secondary outcomes

  1. High risk v/s non-high risk subgroup analysis

    Time frame: one year

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

Sponsors and collaborators

Lead sponsor

Jubilee Mission Medical College and Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2018
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.