Early Discharge After Primary Percutaneous Coronary Intervention

NCT01860079 | Completed Results DMC

• 1 other identifier: the EDAP PCI trial
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief Summary

• 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.

Conditions

ST Elevation Myocardial Infarction

Keywords

Early discharge; STEMI; PPCI

Outcome Measures

Primary Outcomes (1)

• All Cause Mortality and Readmission at 30 Days.

  The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month.

  30 DAYS

Study Arms (2)

Early discharge group

ACTIVE COMPARATOR

In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.

Procedure: early discharge

Standard discharge group

NO INTERVENTION

Patients who stay longer (96-120 hours) as of a standard procedure

Interventions

early discharge PROCEDURE

In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.

Early discharge group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (3)

Acibadem University

Istanbul, Turkey (Türkiye)

Location

Mehmet Akif Ersoy Education and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Siyami Ersek Education and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (14)

• Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9. doi: 10.1056/NEJM199911043411901.

  PMID: 10547403 BACKGROUND

• Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.

  PMID: 12517460 BACKGROUND

• Boersma E; Primary Coronary Angioplasty vs. Thrombolysis Group. Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous coronary intervention and in-hospital fibrinolysis in acute myocardial infarction patients. Eur Heart J. 2006 Apr;27(7):779-88. doi: 10.1093/eurheartj/ehi810. Epub 2006 Mar 2.

  PMID: 16513663 BACKGROUND

• Laarman GJ, Dirksen MT. Early discharge after primary percutaneous coronary intervention. Heart. 2010 Apr;96(8):584-7. doi: 10.1136/hrt.2009.171363. Epub 2009 Sep 23.

  PMID: 19778921 BACKGROUND

• Newby LK, Eisenstein EL, Califf RM, Thompson TD, Nelson CL, Peterson ED, Armstrong PW, Van de Werf F, White HD, Topol EJ, Mark DB. Cost effectiveness of early discharge after uncomplicated acute myocardial infarction. N Engl J Med. 2000 Mar 16;342(11):749-55. doi: 10.1056/NEJM200003163421101.

  PMID: 10717009 BACKGROUND

• Topol EJ, Burek K, O'Neill WW, Kewman DG, Kander NH, Shea MJ, Schork MA, Kirscht J, Juni JE, Pitt B. A randomized controlled trial of hospital discharge three days after myocardial infarction in the era of reperfusion. N Engl J Med. 1988 Apr 28;318(17):1083-8. doi: 10.1056/NEJM198804283181702.

  PMID: 3281014 BACKGROUND

• Grines CL, Marsalese DL, Brodie B, Griffin J, Donohue B, Costantini CR, Balestrini C, Stone G, Wharton T, Esente P, Spain M, Moses J, Nobuyoshi M, Ayres M, Jones D, Mason D, Sachs D, Grines LL, O'Neill W. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol. 1998 Apr;31(5):967-72. doi: 10.1016/s0735-1097(98)00031-x.

  PMID: 9561995 BACKGROUND

• Jirmar R, Widimsky P, Capek J, Hlinomaz O, Groch L. Next day discharge after successful primary angioplasty for acute ST elevation myocardial infarction. An open randomized study "Prague-5". Int Heart J. 2008 Nov;49(6):653-9. doi: 10.1536/ihj.49.653.

  PMID: 19075481 BACKGROUND

• Kotowycz MA, Cosman TL, Tartaglia C, Afzal R, Syal RP, Natarajan MK. Safety and feasibility of early hospital discharge in ST-segment elevation myocardial infarction--a prospective and randomized trial in low-risk primary percutaneous coronary intervention patients (the Safe-Depart Trial). Am Heart J. 2010 Jan;159(1):117.e1-6. doi: 10.1016/j.ahj.2009.10.024.

  PMID: 20102876 BACKGROUND

• Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA. 2001 Aug 8;286(6):708-13. doi: 10.1001/jama.286.6.708.

  PMID: 11495621 BACKGROUND

• Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987 Jul;76(1):142-54. doi: 10.1161/01.cir.76.1.142.

  PMID: 3109764 BACKGROUND

• O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 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 Jan 29;127(4):e362-425. doi: 10.1161/CIR.0b013e3182742cf6. Epub 2012 Dec 17. No abstract available.

  PMID: 23247304 BACKGROUND

• Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit. A two year experience with 250 patients. Am J Cardiol. 1967 Oct;20(4):457-64. doi: 10.1016/0002-9149(67)90023-9. No abstract available.

  PMID: 6059183 BACKGROUND

• Satilmisoglu MH, Gorgulu S, Aksu HU, Aksu H, Ertas G, Tasbulak O, Buturak A, Kalkan AK, Degirmencioglu A, Koroglu B, Tusun E, Murat A, Oz A. Safety of Early Discharge After Primary Percutaneous Coronary Intervention. Am J Cardiol. 2016 Jun 15;117(12):1911-6. doi: 10.1016/j.amjcard.2016.03.039. Epub 2016 Apr 6.

  PMID: 27156829 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Prof.Dr.Şevket Görgülü
• Organization: AcibademU

sevket5@yahoo.com

+902623174444

Study Officials

• Sevket Gorgulu, MD

  Acıbadem University School of Medicine

  STUDY CHAIR

• Tugrul Norgaz, MD

  Acıbadem University School of Medicine

  PRINCIPAL INVESTIGATOR

• Sinan Dagdelen, MD

  Acıbadem 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

• Ali Buturak, MD,

  Acıbadem University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 22, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 7, 2016
• Results First Posted: April 7, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)