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

Study 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.

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

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Procedure: Same-day discharge


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Same-day discharge<br>Same-day discharge following PCI | Procedure: Same-day discharge<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cardiac MACE, major cerebral events, and groin complications |  | 6, 12, and 18 months post study initation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of compliance with dual antiplatelet therapy |  | 6, 12 , and 18 months post study initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrome, percutaneous coronary angioplasty, Troponin negative, cardiac