- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01068119
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
Conditions
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:
- 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
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GREECE
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.
Clinical Trials on Acute Coronary Syndrome
-
Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
-
Meditrix CorpNational University of Ireland, Galway, Ireland; Boston Scientific Japan K.K.; Fujita Health UniversityRecruitingChronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromeJapan, Ireland
-
OrbusNeichDuke Clinical Research Institute; OrbusNeich Medical K.K.CompletedCoronary Arteriosclerosis | Non ST Segment Elevation Acute Coronary SyndromeUnited States, Japan
-
Medical University of WarsawRecruitingAcute Coronary Syndrome | Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromePoland
-
Eli Lilly and CompanyDaiichi Sankyo, Inc.CompletedCoronary Arteriosclerosis | Acute Coronary SyndromesUnited States
-
University of PatrasCompletedCoronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS)Greece
-
Niguarda HospitalCompletedAcute Coronary Syndrome With ST Elevation on Electrocardiogram | Acute Coronary Syndrome Without ST Elevation on Electrocardiogram | Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent | Aortic AneurysmsItaly
-
Sohag UniversityRecruitingLeft Main Coronary Artery Disease With Acute Coronary SyndromeEgypt
-
The First Affiliated Hospital with Nanjing Medical...Unknown
-
Yonsei UniversityCompletedAcute Coronary Syndrome (ACS)Korea, Republic of
Clinical Trials on Same-day discharge
-
Rothman Institute OrthopaedicsThe Anderson Orthopaedic ClinicCompletedOsteoarthritis of the HipUnited States
-
Barretos Cancer HospitalCompleted
-
Massachusetts General HospitalWithdrawnAtrial FibrillationUnited States
-
Indus Hospital and Health NetworkCompletedAngioplasty | CoronaryPakistan
-
Lawson Health Research InstituteActive, not recruiting
-
The Cleveland ClinicCompleted
-
Helse Stavanger HFCompletedCoronary Artery DiseaseNorway
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Heart FailureUnited States
-
Yale UniversityWithdrawnReconstructive Pelvic Surgery
-
George Washington UniversityWithdrawnQuality of Life | Satisfaction | Safety IssuesUnited States