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

Piedmont Healthcare

Status and phase: Terminated; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Procedure: Same-day discharge

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01068119

GREECE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Same-day discharge

Experimental group

Description:

Same-day discharge following PCI

Treatment:

Procedure: Same-day discharge