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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02214082
Other study ID # TIH-Cardio-001
Secondary ID
Status Completed
Phase N/A
First received August 9, 2014
Last updated July 19, 2017
Start date September 2014
Est. completion date October 2015

Study information

Verified date July 2017
Source Indus Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Same Day Discharge
This group will be discharged home, on the same day after their elective angioplasty

Locations

Country Name City State
Pakistan The Indus Hospital Karachi Sind

Sponsors (1)

Lead Sponsor Collaborator
Indus Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Within 30 days post angioplasty
Primary Number of patients who require a 2nd angioplasty within 30 days of 1st angioplasty
Primary Number of patients with bleed from the angioplasty site within 30 days post angioplasty
Secondary number of hospital re-admissions within 30 days of initial angioplasty
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