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

NCT01068119 | Terminated Phase 4

• 1 other identifier: GREECE
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome; percutaneous coronary angioplasty; Troponin negative; cardiac

Outcome Measures

Primary Outcomes (1)

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

  6, 12, and 18 months post study initation

Secondary Outcomes (1)

• Rate of compliance with dual antiplatelet therapy

  6, 12 , and 18 months post study initiation

Study Arms (1)

Same-day discharge

EXPERIMENTAL

Same-day discharge following PCI

Procedure: Same-day discharge

Interventions

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.

Same-day discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piedmont Healthcare: lead
• Medtronic: collaborator

Study Sites (1)

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Dimitrios Karmpaliotis, MD, PhD

  Piedmont Heart Institute/Piedmont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 12, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: March 1, 2012
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

US (1)