Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention

• Sponsor: Indus Hospital and Health Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT02214082
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 16.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Angioplasty; Coronary	Other: Same Day Discharge	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility and Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention (PCI) in a Tertiary Care Hospital in Karachi, Pakistan.
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mortality [Within 30 days post angioplasty]

2. Number of patients who require a 2nd angioplasty [within 30 days of 1st angioplasty]

3. Number of patients with bleed from the angioplasty site [within 30 days post angioplasty]

Secondary Outcome Measures

1. number of hospital re-admissions [within 30 days of initial angioplasty]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Indus Hospital	Karachi	Sind	Pakistan

Sponsors and Collaborators

• Indus Hospital and Health Network

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sajid H. Dhakam, Faculty, Cardiology, Indus Hospital and Health Network
• ClinicalTrials.gov Identifier: NCT02214082
• Other Study ID Numbers: TIH-Cardio-001
• First Posted: Aug 12, 2014
• Last Update Posted: Jul 21, 2017
• Last Verified: Jul 1, 2017

Study Results

No Results Posted as of Jul 21, 2017