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

NCT ID: NCT01068119

Last Updated: 2013-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Keywords

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Acute coronary syndrome percutaneous coronary angioplasty Troponin negative cardiac

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Same-day discharge

Same-day discharge following PCI

Group Type EXPERIMENTAL

Same-day discharge

Intervention Type 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.

Interventions

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Same-day discharge

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Piedmont Healthcare

OTHER

Sponsor Role lead

Responsible Party

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Piedmont Heart Institute/Piedmont Hospital

Principal Investigators

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Dimitrios Karmpaliotis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute/Piedmont Hospital

Locations

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Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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GREECE

Identifier Type: -

Identifier Source: org_study_id