Outpatient Percutaneous Coronary Intervention | NCT00419055

Studies
Outpatient Percutaneous Coronary Intervention

NCT00419055

Sponsor

University of Pennsylvania

Status

Terminated

Last Update Posted

Apr 2, 2012Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Early discharge after percutaneous coronary intervenntion

Countries

Not provided

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped early due to inability to recruit full 100 subjects over 2 years

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

Aug 2006Actual

First Submitted Date

Jan 4, 2007

First Submission Date that Met QC Criteria

Jan 4, 2007

First Posted Date

Jan 8, 2007Estimated

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

Mar 29, 2012

Last Update Posted Date

Apr 2, 2012Estimated

Name	Class
Abbott Medical Devices	INDUSTRY
The Medicines Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population. The hypothesis to be tested is that in an appropriately selected stable coronary artery disease population post percutaneous coronary intervention, early discharge is safe and feasible.

Detailed Description

A select stable population of patients undergoing percutaneous coronary intervention are randomized to standard of care in-hospital stay for one night or early discharge to a nearby hotel. During PCI, patients receive bivalirudin as their anti-coagulant and also must be eligible for an angioseal closure device. Patients that stay overnight in the hotel must be accompanied by a family member. They return to the cath lab the next day for groin check and blood work. Satisfaction questionnaires are filled out by all patients.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 Control		Patients are discharged the day after PCI	Procedure: Early discharge after percutaneous coronary intervenntion
2 Study group		Patients will be discharged 4-6 hrs after PCI	Procedure: Early discharge after percutaneous coronary intervenntion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early discharge after percutaneous coronary intervenntion	Procedure	Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.

Measure	Description	Time Frame
The primary endpoints are patient satisfaction and safety.		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention

Exclusion Criteria:

Patients with acute coronary syndrome, patients with an MI within 30 days, an ejection fraction <30%, those with history of IV Dye allergy, creatinine level>2.2, those with increased risk of infection, those with history of bleeding diathesis or anemia (hemoglobin<11.0 g/dl, platelets <100,000 tho/ul)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients less than 75 years who have undergone PCI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Howard C Herrmann, M.D.	University of Pennsylvania	Principal Investigator
Ruchira Glaser, M.D.	University of Pennsylvania	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided