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

September 20, 2013 updated by: Piedmont Healthcare

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

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.

Study Overview

Status

Terminated

Intervention / Treatment

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

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Same-day discharge
Same-day discharge following PCI
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Dimitrios Karmpaliotis, MD, PhD, Piedmont Heart Institute/Piedmont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 11, 2010

First Posted (Estimate)

February 12, 2010

Study Record Updates

Last Update Posted (Estimate)

September 23, 2013

Last Update Submitted That Met QC Criteria

September 20, 2013

Last Verified

September 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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