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Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214082
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Sajid H. Dhakam, Indus Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Mortality [ Time Frame: Within 30 days post angioplasty ]
  2. Number of patients who require a 2nd angioplasty [ Time Frame: within 30 days of 1st angioplasty ]
  3. Number of patients with bleed from the angioplasty site [ Time Frame: within 30 days post angioplasty ]

Secondary Outcome Measures :
  1. number of hospital re-admissions [ Time Frame: within 30 days of initial angioplasty ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214082


Locations
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Pakistan
The Indus Hospital
Karachi, Sind, Pakistan
Sponsors and Collaborators
Indus Hospital
Investigators
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Principal Investigator: Sajid Dhakam Indus Hospital

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Responsible Party: Sajid H. Dhakam, Faculty, Cardiology, Indus Hospital
ClinicalTrials.gov Identifier: NCT02214082    
Other Study ID Numbers: TIH-Cardio-001
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017