Acute Coronary SyndromePhase 4GREECENCT01068119
Same-Day Discharge After Coronary Percutaneous Transluminal Coronary Angioplasty (PTCA)
A Phase 4 study testing Same-day discharge in people with Acute Coronary Syndrome, run by Piedmont Healthcare at 1 site in United States.
Trial summary
Same day discharge is safe and feasible in selected troponin negative patients undergoing coronary planned percutaneous coronary intervention (PCI) or ad hoc PCI via the transfemoral approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Same-day discharge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2012
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for catheterization/coronary angiography
- Undergoing diagnostic coronary angiography to define the coronary anatomy with the intent for revascularization (ad-hoc PCI) or planned PCI to define the coronary anatomy with the intent for revascularization due to one of the following:
- exertional or rest chest pain (or angina equivalent)
- abnormal Exercise Stress Test
- abnormal nuclear tests
- abnormal pharmacologic or stress echocardiogram, or pharmacologic MRI
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- abnormal EKGs
- abnormal Calcium scores
- abnormal coronary CT angiogram
- Ability and willingness to consent and Authorization for use of PHI
Who cannot join
- ACS (STEMI, UA/NSTEMI)
- Positive Troponin I per local laboratory standards
- Known EF<30%
- GFR<50% (calculation using the IDMS-Traceable MDRD study equation
- Dye Allergy that unable to be safely premedicated
- Known current or history of bleeding diathesis
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- Current or anticipated treatment with warfarin, oral factor Xa inhibitor, oral direct thrombin inhibitor, LMWH, or TNK
- Known platelet count <100,000/mm³ or known INR >1.5 at time of enrollment
- Hgb <10 g/dL and/or Hct < 30%
- Residence >60 minutes from the hospital
- Reliable caregiver not available for home post PCI recovery
- Participation in another study that would require hospital procedures or test post PCI prior to discharge
- Inability or unwillingness to consent for study, follow up procedures and Authorization for use of PHI
- Physician clinical determination participant is not suitable for study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of Same-Day Discharge of Troponin Negative Patients After Coronary PTCA Via the Transfemoral Approach
Same day discharge is safe and feasible in selected troponin negative patients undergoing coronary planned percutaneous coronary intervention (PCI) or ad hoc PCI via the transfemoral approach.
Read the detailed description
The feasibility and safety of same day discharge post PCI will be examined. Study data will be compared to national registries and national or regional databases of PCI in Troponin negative patients with overnight stay. As part of the registry we will also assess compliance with dual antiplatelet therapy at six months and at 1 year and will record any reasons for premature discontinuation as well as any associated adverse events.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Same-day discharge
- Keywords
- Acute coronary syndrome, percutaneous coronary angioplasty, Troponin negative, cardiac
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-day dischargeProcedure or surgery
Patients identified as clinically stable are discharged home the same day as the PCI procedure with telephone follow-up at 12 hr, 24 hr, 3, 30, 180 and 365 days post procedure.
| Study group | Role | What they receive |
|---|---|---|
| Same-day discharge | Experimental | Same-day discharge following PCI Receives: Procedure: Same-day discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cardiac MACE, major cerebral events, and groin complications
Measured: 6, 12, and 18 months post study initation
Secondary outcomes (1)
Rate of compliance with dual antiplatelet therapy
Measured: 6, 12 , and 18 months post study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionMar 2012
Why it stopped: Slow enrollment and high number of screen failures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Dimitrios Karmpaliotis, MD, PhD, Principal investigator, Piedmont Heart Institute/Piedmont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068119
- Sponsor's protocol ID
- GREECE
- Acronym
- GREECE
- Status last verified
- Sep 2013
- First submitted
- 11 Feb 2010
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Same-Day Discharge of Troponin Negative Patients After Coronary PTCA Via the Transfemoral Approach
- ClinicalTrials.gov ID
- NCT01068119
- Acronym / sponsor ID
- GREECE / GREECE
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, percutaneous coronary angioplasty, Troponin negative, cardiac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and high number of screen failures
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Feb 2010 (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.
Same day discharge is safe and feasible in selected troponin negative patients undergoing coronary planned percutaneous coronary intervention (PCI) or ad hoc PCI via the transfemoral approach.
Detailed description
The feasibility and safety of same day discharge post PCI will be examined. Study data will be compared to national registries and national or regional databases of PCI in Troponin negative patients with overnight stay. As part of the registry we will also assess compliance with dual antiplatelet therapy at six months and at 1 year and will record any reasons for premature discontinuation as well as any associated adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Same-day discharge | Experimental | Procedure: Same-day dischargeSame-day discharge following PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Scheduled for catheterization/coronary angiography
- Undergoing diagnostic coronary angiography to define the coronary anatomy with the intent for revascularization (ad-hoc PCI) or planned PCI to define the coronary anatomy with the intent for revascularization due to one of the following:
- Ability and willingness to consent and Authorization for use of PHI
Key exclusion criteria (14 listed)
- ACS (STEMI, UA/NSTEMI)
- Positive Troponin I per local laboratory standards
- Known EF<30%
- GFR<50% (calculation using the IDMS-Traceable MDRD study equation
- Dye Allergy that unable to be safely premedicated
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 dischargePatients identified as clinically stable are discharged home the same day as the PCI procedure with telephone follow-up at 12 hr, 24 hr, 3, 30, 180 and 365 days post procedure. | Procedure or surgery | Same-day discharge |
Primary outcome
Number of cardiac MACE, major cerebral events, and groin complications
Time frame: 6, 12, and 18 months post study initation
1 secondary outcome
Rate of compliance with dual antiplatelet therapy
Time frame: 6, 12 , and 18 months post study initiation
Results and safety
The study was stopped early (reason given: Slow enrollment and high number of screen failures). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
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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.
Dimitrios Karmpaliotis, MD, PhD principal investigator
Piedmont Heart Institute/Piedmont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Same-day discharge in people with Acute Coronary Syndrome, run by Piedmont Healthcare at 1 site in United States.
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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 23 Sep 2013. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment and high number of screen failures). Results are not available in the source record.
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?
Number of cardiac MACE, major cerebral events, and groin complications (time frame: 6, 12, and 18 months post study initation). 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 23 Sep 2013.