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

NCT03488407 | Completed

• 1 other identifier: 2/16/IEC/JMMC&RI
• Study Type: observational
• Target: 315
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Angioplasty

Keywords

Primary angioplasty; Radial access; STEMI

Outcome Measures

Primary Outcomes (2)

• Evaluation of radial angioplasty success in whole cohort.

  Angioplasty success rate (by TIMI flow grade)

  one year

• Evaluation of in-hospital complication.

  Rate of local complications

  One year

Secondary Outcomes (1)

• High risk v/s non-high risk subgroup analysis

  one year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients presenting with STEMI and being considered for primary PCI through radial access between March 2016 and Feb 2017.

You may not qualify if:

• Patients with ACS other than STEMI
• All primary PCI in STEMI through femoral access.
• All radial elective PCI.

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Rajesh Sharma, MD

  Jubilee Mission Medical College & Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: April 5, 2018
• Study Start: March 5, 2016
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-03