Same-Day Discharge After Coronary Percutaneous Translumin... | NCT01068119

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

NCT01068119

Sponsor

Piedmont Healthcare

Status

Terminated

Last Update Posted

Sep 23, 2013Estimated

Enrollment

57Actual

Phase

Phase 4

Conditions

Acute Coronary Syndrome

Interventions

Same-day discharge

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow enrollment and high number of screen failures

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Feb 11, 2010

First Submission Date that Met QC Criteria

Feb 11, 2010

First Posted Date

Feb 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2013

Last Update Posted Date

Sep 23, 2013Estimated

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Same-day discharge	Experimental	Same-day discharge following PCI	Procedure: Same-day discharge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Same-day discharge	Procedure	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.

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

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

Eligibility Module

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:
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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases