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

Primary Angioplasty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488407
• Other study ID #: 2/16/IEC/JMMC&RI
• Status: Completed
• First received: March 3, 2018
• Last updated: March 28, 2018
• Start date: March 5, 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: March 2018
• Source: Jubilee Mission Medical College and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Angioplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jubilee Mission Medical College and Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of radial angioplasty success in whole cohort.	Angioplasty success rate (by TIMI flow grade)	one year
Primary	Evaluation of in-hospital complication.	Rate of local complications	One year
Secondary	High risk v/s non-high risk subgroup analysis	Non- inferiority of radial angioplasty for high risk group were assessed.	one year