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

Piedmont Healthcare1 site in 1 country57 target enrollmentFebruary 2010

ConditionsAcute Coronary Syndrome

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Acute Coronary Syndrome
Sponsor: Piedmont Healthcare
Enrollment: 57
Locations: 1
Primary Endpoint: Number of cardiac MACE, major cerebral events, and groin complications
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

March 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Piedmont Healthcare

Eligibility Criteria

Inclusion Criteria

•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
•abnormal EKGs
•abnormal Calcium scores
•abnormal coronary CT angiogram
•Ability and willingness to consent and Authorization for use of PHI

Exclusion Criteria

•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
•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