Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention

Feasibility and Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention (PCI) in a Tertiary Care Hospital in Karachi, Pakistan.

Study intends to determine if there is any difference in the occurrence of major adverse cardiology events in patients discharged on the same day as their elective cardiac angioplasty or discharged one day after their angioplasty.

Hypothesize that same day discharge is as safe as a day later discharge.

Study Overview

• Status: Completed
• Conditions: Angioplasty; Coronary
• Intervention / Treatment: Other: Same Day Discharge

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan
      • The Indus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: :

• Low risk lesion (according to the ACC classification)
• Normal Pre Catheterization laboratory investigation
• Procedure performed before 3 pm
• procedure performed with ≤ 6 French guiding Catheter
• EF ≥ 35%
• living at a distance of within 15 kilometers from hospital
• caregiver present at home
• elective procedure

Exclusion Criteria:

• Acute PCI
• high risk lesions (according to the ACC classification)
• deranged Pre Catheterization laboratory investigations
• Age >70
• Severe LV dysfunction, CVA
• procedure to be performed with a guiding catheter >6F
• Use of IIb/IIIa inhibitor
• Creatinine clearance of < 50

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Next day discharge; this group will be discharged as is the standard practice at our facility; i.e. the day after the PCI procedure
Experimental: Same Day Discharge; Patients in this arm will be discharged on the same day as their angioplasty.	Other: Same Day Discharge; This group will be discharged home, on the same day after their elective angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	Within 30 days post angioplasty
Number of patients who require a 2nd angioplasty	within 30 days of 1st angioplasty
Number of patients with bleed from the angioplasty site	within 30 days post angioplasty

Secondary Outcome Measures

Outcome Measure	Time Frame
number of hospital re-admissions	within 30 days of initial angioplasty

Collaborators and Investigators

• Sponsor: Indus Hospital and Health Network
• Investigators: Principal Investigator: Sajid Dhakam, Indus Hospital and Health Network

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 9, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (Estimate): August 12, 2014

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: TIH-Cardio-001