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

A Prospective Study to Evaluate Feasibility of Routine Use of Radial Access for Primary Angioplasty and to Assess it in Subgroups With Unfavorable Characteristics

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03488407
Enrollment
315
Registered
2018-04-05
Start date
2016-03-05
Completion date
2017-02-28
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Angioplasty

Keywords

Primary angioplasty, Radial access, STEMI

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.

Interventions

None listed

Sponsors

Jubilee Mission Medical College and Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of radial angioplasty success in whole cohort.one yearAngioplasty success rate (by TIMI flow grade)
Evaluation of in-hospital complication.One yearRate of local complications

Secondary

MeasureTime frameDescription
High risk v/s non-high risk subgroup analysisone yearNon- inferiority of radial angioplasty for high risk group were assessed.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026