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

Phase 4

Terminated

• Conditions: Acute Coronary Syndrome
• Interventions: Procedure: Same-day discharge

• Registration Number: NCT01068119
• Lead Sponsor: Piedmont Healthcare

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Primary Completion: 2011-08
• Study Completion: 2012-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-20
• Last Update Posted: 2013-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Same-day discharge	Same-day discharge	Same-day discharge following PCI

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States