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
Verified date | March 2018 |
Source | Jubilee Mission Medical College and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Jubilee Mission Medical College and Research Institute |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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