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

This study has been terminated.
(Slow enrollment and high number of screen failures)
Sponsor:
Collaborator:
Medtronic
Information provided by:
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01068119
First received: February 11, 2010
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Procedure: Same-day discharge
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Safety of Same-Day Discharge of Troponin Negative Patients After Coronary PTCA Via the Transfemoral Approach

Resource links provided by NLM:


Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • Number of cardiac MACE, major cerebral events, and groin complications [ Time Frame: 6, 12, and 18 months post study initation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of compliance with dual antiplatelet therapy [ Time Frame: 6, 12 , and 18 months post study initiation ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Same-day discharge
Same-day discharge following PCI
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068119

Locations
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
Medtronic
Investigators
Principal Investigator: Dimitrios Karmpaliotis, MD, PhD Piedmont Heart Institute/Piedmont Hospital
  More Information

No publications provided

Responsible Party: Dimitrios Karmpaliotis, MD, PhD, Piedmont Heart Institute/Piedmont Hospital
ClinicalTrials.gov Identifier: NCT01068119     History of Changes
Other Study ID Numbers: GREECE
Study First Received: February 11, 2010
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Piedmont Healthcare:
Acute coronary syndrome
percutaneous coronary angioplasty
Troponin negative
cardiac

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014