NCT02214082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

August 9, 2014

Last Update Submit

July 19, 2017

Conditions

AngioplastyCoronary

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • number of hospital re-admissions

    within 30 days of initial angioplasty

Study Arms (2)

Next day discharge

NO INTERVENTION

this group will be discharged as is the standard practice at our facility; i.e. the day after the PCI procedure

Same Day Discharge

EXPERIMENTAL

Patients in this arm will be discharged on the same day as their angioplasty.

Other: Same Day Discharge

Interventions

Same Day DischargeOTHER

This group will be discharged home, on the same day after their elective angioplasty

Same Day Discharge

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Indus Hospital

Karachi, Sindh, Pakistan

Location

Study Officials

  • Sajid Dhakam

    Indus Hospital and Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty, Cardiology

Study Record Dates

First Submitted

August 9, 2014

First Posted

August 12, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

PA(1)