Clinical trial NCT03488407: Evaluation of Feasibility of Radial Access for Primary Angioplasty and to Assess it in High Risk Subgroups
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Angioplasty
Keywords: Primary angioplasty
Radial access
STEMI
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 315
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All prospective patients presenting with STEMI and being considered for primary PCI through radial access between March 2016 to Feb 2017.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of radial angioplasty success in whole cohort.
timeFrame: one year
measure: Evaluation of in-hospital complication.
timeFrame: One year
Secondary outcomes:
measure: High risk v/s non-high risk subgroup analysis
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Jubilee Mission Medical College & Research Institute
name: Rajesh Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: