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

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ClinicalTrials.gov Identifier: NCT01068119
Recruitment Status : Terminated (Slow enrollment and high number of screen failures)
First Posted : February 12, 2010
Last Update Posted : September 23, 2013
Sponsor:
Collaborator:
Medtronic
Information provided by:
Piedmont Healthcare

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Procedure: Same-day discharge Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : March 2012

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of cardiac MACE, major cerebral events, and groin complications [ Time Frame: 6, 12, and 18 months post study initation ]

Secondary Outcome Measures :
  1. Rate of compliance with dual antiplatelet therapy [ Time Frame: 6, 12 , and 18 months post study initiation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dimitrios Karmpaliotis, MD, PhD, Piedmont Heart Institute/Piedmont Hospital
ClinicalTrials.gov Identifier: NCT01068119     History of Changes
Other Study ID Numbers: GREECE
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013

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
Vascular Diseases