Same-Day Discharge After Coronary Percutaneous Transluminal Coronary Angioplasty (PTCA)

Feasibility and Safety of Same-Day Discharge of Troponin Negative Patients After Coronary PTCA Via the Transfemoral Approach

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01068119

Acronym

GREECE

Enrollment

Registered

2010-02-12

Start date

2010-02-28

Completion date

2012-03-31

Last updated

2013-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome, percutaneous coronary angioplasty, Troponin negative, cardiac

Brief 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.

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.

Interventions

PROCEDURESame-day discharge

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Scheduled for catheterization/coronary angiography 2. 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: 1. exertional or rest chest pain (or angina equivalent) 2. abnormal Exercise Stress Test 3. abnormal nuclear tests 4. abnormal pharmacologic or stress echocardiogram, or pharmacologic MRI 5. abnormal EKGs 6. abnormal Calcium scores 7. abnormal coronary CT angiogram 3. Ability and willingness to consent and Authorization for use of PHI

Exclusion criteria

1. ACS (STEMI, UA/NSTEMI) 2. Positive Troponin I per local laboratory standards 3. Known EF\<30% 4. GFR\<50% (calculation using the IDMS-Traceable MDRD study equation 5. Dye Allergy that unable to be safely premedicated 6. Known current or history of bleeding diathesis 7. Current or anticipated treatment with warfarin, oral factor Xa inhibitor, oral direct thrombin inhibitor, LMWH, or TNK 8. Known platelet count \<100,000/mm³ or known INR \>1.5 at time of enrollment 9. Hgb \<10 g/dL and/or Hct \< 30% 10. Residence \>60 minutes from the hospital 11. Reliable caregiver not available for home post PCI recovery 12. Participation in another study that would require hospital procedures or test post PCI prior to discharge 13. Inability or unwillingness to consent for study, follow up procedures and Authorization for use of PHI 14. Physician clinical determination participant is not suitable for study participation

Design outcomes

Primary

Measure	Time frame
Number of cardiac MACE, major cerebral events, and groin complications	6, 12, and 18 months post study initation

Secondary

Measure	Time frame
Rate of compliance with dual antiplatelet therapy	6, 12 , and 18 months post study initiation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026