Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention

NCT ID: NCT02214082

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Angioplasty Coronary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Next day discharge

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Same Day Discharge

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

Group Type EXPERIMENTAL

Same Day Discharge

Intervention Type OTHER

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

Interventions

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Same Day Discharge

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indus Hospital and Health Network

OTHER

Sponsor Role lead

Responsible Party

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Sajid H. Dhakam

Faculty, Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sajid Dhakam

Role: PRINCIPAL_INVESTIGATOR

Indus Hospital and Health Network

Locations

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The Indus Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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TIH-Cardio-001

Identifier Type: -

Identifier Source: org_study_id

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