Clinical trial NCT01068119: Same-Day Discharge After Coronary Percutaneous Transluminal Coronary Angioplasty (PTCA)
Official title: Feasibility and Safety of Same-Day Discharge of Troponin Negative Patients After Coronary PTCA Via the Transfemoral Approach
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary syndrome
percutaneous coronary angioplasty
Troponin negative
cardiac
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2010-02-12
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of cardiac MACE, major cerebral events, and groin complications
timeFrame: 6, 12, and 18 months post study initation
Secondary outcomes:
measure: Rate of compliance with dual antiplatelet therapy
timeFrame: 6, 12 , and 18 months post study initiation
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
Study officials:
affiliation: Piedmont Heart Institute/Piedmont Hospital
name: Dimitrios Karmpaliotis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: