AngioplastyNCT02214082
Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention
A study testing Same Day Discharge in people with Angioplasty and Coronary, run by Indus Hospital and Health Network at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Angioplasty, Coronary
- What is being tested?
- Same Day Discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention (PCI) in a Tertiary Care Hospital in Karachi, Pakistan.
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.
- Conditions
- Angioplasty, Coronary
- Being tested
- Same Day Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same Day DischargeOther
This group will be discharged home, on the same day after their elective angioplasty
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Same Day Discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Within 30 days post angioplasty
Number of patients who require a 2nd angioplasty
Measured: within 30 days of 1st angioplasty
Number of patients with bleed from the angioplasty site
Measured: within 30 days post angioplasty
Secondary outcomes (1)
number of hospital re-admissions
Measured: within 30 days of initial angioplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indus Hospital and Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sajid H. Dhakam, Indus Hospital and Health Network
- Investigators
- Sajid Dhakam, Principal investigator, Indus Hospital and Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214082
- Sponsor's protocol ID
- TIH-Cardio-001
- Status last verified
- Jul 2017
- First submitted
- 9 Aug 2014
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention (PCI) in a Tertiary Care Hospital in Karachi, Pakistan.
- ClinicalTrials.gov ID
- NCT02214082
- Acronym / sponsor ID
- TIH-Cardio-001
- Conditions
- Angioplasty, Coronary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Indus Hospital and Health NetworkUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Same Day DischargePatients in this arm will be discharged on the same day as their angioplasty. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (8 listed)
- Acute PCI
- high risk lesions (according to the ACC classification)
- deranged Pre Catheterization laboratory investigations
- Age >70
- Severe LV dysfunction, CVA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same Day DischargeThis group will be discharged home, on the same day after their elective angioplasty | Other | Same Day Discharge |
Primary outcome
Mortality
Time frame: Within 30 days post angioplasty
Number of patients who require a 2nd angioplasty
Time frame: within 30 days of 1st angioplasty
Number of patients with bleed from the angioplasty site
Time frame: within 30 days post angioplasty
1 secondary outcome
number of hospital re-admissions
Time frame: within 30 days of initial angioplasty
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sajid Dhakam principal investigator
Indus Hospital and Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same Day Discharge in people with Angioplasty and Coronary, run by Indus Hospital and Health Network at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Within 30 days post angioplasty). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.