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

Acute Coronary Syndrome Clinical Trial

— GREECE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01068119
• Other study ID #: GREECE
• Status: Terminated
• Phase: Phase 4
• First received: February 11, 2010
• Last updated: September 20, 2013
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2013
• Source: Piedmont Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Procedure:
• Same-day discharge
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.

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Piedmont Healthcare	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cardiac MACE, major cerebral events, and groin complications		6, 12, and 18 months post study initation	Yes
Secondary	Rate of compliance with dual antiplatelet therapy		6, 12 , and 18 months post study initiation	No