Early Discharge After Primary Percutaneous Coronary Intervention (EDAPPCI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Acibadem University
Sponsor:
Information provided by (Responsible Party):
Acibadem University
ClinicalTrials.gov Identifier:
NCT01860079
First received: May 16, 2013
Last updated: July 11, 2013
Last verified: July 2013
  Purpose
  • When Primary percutaneous coronary intervention (PPCI) is performed expeditiously and at a high-volume centre, it is the optimal approach for ST elevation myocardial infarction (STEMI) . In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge.
  • An early discharge strategy may be desired by all parties (financial health care provider, treating physician, nurse, patient, patient's relatives)involved in STEMI.
  • The main goal in our study is to test the hypothesis that an early discharge strategy within 48-56 hours in patients with successful PPCI is as safe as in those patients who stay longer (96-120 hours) as of a standard procedure.

Condition Intervention
ST Elevation Myocardial Infarction
Primary Percutaneous Coronary Intervention
Procedure: early discharge

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Discharge After Primary Percutaneous Coronary Intervention: A Prospective Randomized Multi-center Trial (the EDAP PCI Trial)

Resource links provided by NLM:


Further study details as provided by Acibadem University:

Primary Outcome Measures:
  • number of participants with adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    The primary outcome is the number of participants with adverse events such as all cause mortality and readmission at 4 weeks.


Estimated Enrollment: 1000
Study Start Date: May 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early discharge group
In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
Procedure: early discharge
In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
No Intervention: Standard discharge group
Patients who stay longer (96-120 hours) as of a standard procedure

Detailed Description:
  • Primary percutaneous coronary intervention (PPCI) has become the optimal reperfusion strategy for ST elevation myocardial infarction (STEMI) when the procedure is performed expeditiously and at a high-volume centre.In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge.
  • It is conceivable to discharge patients with successful PPCI as early as possible, because a hospital stay longer than needed may create undesirable outcomes in terms of hospital infections, psychosocial reasons, adequate mobilization and patient comfort. In many tertiary centres with a busy PPCI programme insufficient bed capacity is an ongoing concern and threatens the continuous acceptance of new cases of acute infarctions. In addition, it has been indicated that an early discharge policy may lead to a substantial cost saving.
  • Although much work has been done in developing and validating risk scores that identify low risk patients, data on the implementation of early discharge strategies have been quite limited There are 3 randomised trials investigating the possibility of early discharge after PPCI. However, certain limitations of these studies are preventing to implement an early discharge strategy in all-comers, particularly because of the underrepresentation of older patients in clinical trials. The verification of this policy is also needed in patients with multivessel disease. The first prospective randomized trial, the PAMI II,7 is partly obsolete as major changes have been made in PPCI with respect to devices and adjunctive medication. The other two randomized trials were single-center pilot studies with small number of patients.
  • Therefore, the above mentioned literature information warrants to test the reproducibility of safety endpoints in a large scale multicenter trial, prior to application of the early discharge strategy in clinical practice.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent and subsequent written agreement of a family member (confirming good social background)
  • Acute STEMI, defined as >30 minutes of continuous typical chest pain and ST-segment elevation ≥2 mm in two contiguous electrocardiography leads and /or left bundle branch block within 12 hours of symptom onset.
  • Haemodynamically stable Angiographically
  • Successful PPCI procedure (TIMI 2-3 flow and %<20 residual stenosis) and an uneventful 24 hour follow up period
  • Single epicardial artery to be treated
  • Telephone contact between the patient and PCI center after discharge is available 24 hours daily

Exclusion Criteria:

  • Inability to consent
  • Patients treated with thrombolytic agents for the index STEMI
  • Cardiogenic shock,
  • Stroke within a month,
  • Signs of heart failure (Killip II-IV)
  • Hypotension (<100 mmHg SBP) persisting after PPCI
  • Chest pain recurrence
  • Clinically significant arrhythmia (requiring treatment) occurring >6 hours after PPCI.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860079

Contacts
Contact: Sevket Gorgulu, MD +902623174444 ext 4123 sevket5@yahoo.com
Contact: Hüseyin Uyarel, MD +902124531700 ext 1691 uyarel@yahoo.com

Locations
Turkey
Acibadem University Recruiting
İstanbul, Turkey
Contact: norgaz, MD       tnorgaz@yahoo.com   
Principal Investigator: Ali Buturak, MD         
Bezmialem University School of Medicine Not yet recruiting
Istanbul, Turkey
Principal Investigator: Mehmet Ergelen, MD         
Siyami Ersek Education and Training Hospital Recruiting
Istanbul, Turkey
Principal Investigator: Mehmet Eren, MD         
Mehmet Akif Ersoy Education and Training Hospital Recruiting
Istanbul, Turkey
Contact: Uslu       dr.nuslu@yahoo.com   
Principal Investigator: Nevzat Uslu, MD         
Sponsors and Collaborators
Acibadem University
Investigators
Study Chair: Sevket Gorgulu, MD Acibadem University, School of Medicine
Study Director: Huseyin Uyarel, MD Bezmialem University School of medicine
Principal Investigator: Tugrul Norgaz, MD Acibadem University, School of Medicine
Principal Investigator: Sinan Dagdelen, MD Acibadem University, School Of Medicine
Principal Investigator: Nevzat Uslu, MD Mehmet Akif Ersoy Education and Training Hospital
Principal Investigator: Aydin Yildirim, MD Siyami Ersek Educational and Training Hospital
Principal Investigator: Mehmet Ergelen, MD Bezmialem University School of Medicine
Principal Investigator: Ali Buturak, MD, Acibadem University School of Medicine
  More Information

Publications:
O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, et al. 2013 ACCF/AHA guideline for the management of ST elevation myocardial infarction: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. Circulation 2013;127:e362-425.

Responsible Party: Acibadem University
ClinicalTrials.gov Identifier: NCT01860079     History of Changes
Other Study ID Numbers: the EDAP PCI trial
Study First Received: May 16, 2013
Last Updated: July 11, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Acibadem University:
Early discharge
STEMI
PPCI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014