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

Primary Purpose

Acute Coronary Syndrome

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Same-day discharge
Sponsored by
Piedmont Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, percutaneous coronary angioplasty, Troponin negative, cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Piedmont Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Same-day discharge

Arm Description

Same-day discharge following PCI

Outcomes

Primary Outcome Measures

Number of cardiac MACE, major cerebral events, and groin complications

Secondary Outcome Measures

Rate of compliance with dual antiplatelet therapy

Full Information

First Posted
February 11, 2010
Last Updated
September 20, 2013
Sponsor
Piedmont Healthcare
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01068119
Brief Title
Same-Day Discharge After Coronary Percutaneous Transluminal Coronary Angioplasty (PTCA)
Acronym
GREECE
Official Title
Feasibility and Safety of Same-Day Discharge of Troponin Negative Patients After Coronary PTCA Via the Transfemoral Approach
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment and high number of screen failures
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Piedmont Healthcare
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute coronary syndrome, percutaneous coronary angioplasty, Troponin negative, cardiac

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Same-day discharge
Arm Type
Experimental
Arm Description
Same-day discharge following PCI
Intervention Type
Procedure
Intervention Name(s)
Same-day discharge
Intervention Description
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 Measure Information:
Title
Number of cardiac MACE, major cerebral events, and groin complications
Time Frame
6, 12, and 18 months post study initation
Secondary Outcome Measure Information:
Title
Rate of compliance with dual antiplatelet therapy
Time Frame
6, 12 , and 18 months post study initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for catheterization/coronary angiography 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: exertional or rest chest pain (or angina equivalent) abnormal Exercise Stress Test abnormal nuclear tests abnormal pharmacologic or stress echocardiogram, or pharmacologic MRI abnormal EKGs abnormal Calcium scores abnormal coronary CT angiogram Ability and willingness to consent and Authorization for use of PHI Exclusion Criteria: ACS (STEMI, UA/NSTEMI) Positive Troponin I per local laboratory standards Known EF<30% GFR<50% (calculation using the IDMS-Traceable MDRD study equation Dye Allergy that unable to be safely premedicated Known current or history of bleeding diathesis Current or anticipated treatment with warfarin, oral factor Xa inhibitor, oral direct thrombin inhibitor, LMWH, or TNK Known platelet count <100,000/mm³ or known INR >1.5 at time of enrollment Hgb <10 g/dL and/or Hct < 30% Residence >60 minutes from the hospital Reliable caregiver not available for home post PCI recovery Participation in another study that would require hospital procedures or test post PCI prior to discharge Inability or unwillingness to consent for study, follow up procedures and Authorization for use of PHI Physician clinical determination participant is not suitable for study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitrios Karmpaliotis, MD, PhD
Organizational Affiliation
Piedmont Heart Institute/Piedmont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States

12. IPD Sharing Statement

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

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