Safety of Early Discharge Following Low Risk Myocardial Infarction

NCT01868256 | Unknown DMC

• 1 other identifier: IIBSP-PAP-2011-07
• Study Type: interventional
• Target: 1,558
• Locations: 1 country
• Sites: 1

Brief Summary

• Objectives: The primary objective of this study is to evaluate the safety of an early discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI), compared to a conventional strategy.
• Methodology: Unicentric, randomized, controlled, non-inferiority and open label clinical trial. The investigators will compare an early discharge strategy (≤72 hours) with a conventional strategy (discharge according to treating physician's criterion). Inclusion criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset. Exclusion criteria will be: arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding (according to the GUSTO criteria), complications related to vascular access of the procedure, acute kidney failure, infection, heart failure. Sample size will be 1558 subjects (n=779 per group). The investigators will study demographic, clinical, biochemical, echocardiographic and angiographic variables. The primary endpoint will be a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. The secondary endpoint will include each of the items of the primary endpoint and quality of life and functional capacity questionnaire SF-36. Finally, the investigators will analyze the degree of compliance with the European Society of Cardiology guidelines on STEMI and the rate of hospitalization-related complications. Follow up will be at 30 days.

Conditions

Myocardial Infarction

Keywords

myocardial infarction; primary percutaneous intervention; prognosis; early discharge

Outcome Measures

Primary Outcomes (1)

• All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding.

  Composite primary end-point

  1 month

Secondary Outcomes (7)

• All cause mortality

  1 month

• Myocardial infarction

  1 month

• Unstable angina

  1 month

• Heart failure

  1 month

• Ventricular arrhythmias

  1 month

Other Outcomes (2)

• Difference in quality of life and functional capacity questionnaire SF-36.

  1 month

• Compliance of treatment

  1 month

Study Arms (2)

Early discharge (< 72 h)

EXPERIMENTAL

Patients randomized the early discharge group will be discharged from the hospital in \< 72 hours

Other: early discharge (<72 h)

Conventional discharge

ACTIVE COMPARATOR

Patients randomized to the conventional discharge group will be discharged according to the local hospital protocol and/or treating physician criterion

Other: Conventional discharge

Interventions

early discharge (<72 h) OTHER

Early discharge (< 72 h)

Conventional discharge OTHER

Conventional discharge

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset
• Informed consent

You may not qualify if:

• arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block)
• mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis)
• severe or moderate bleeding (according to the GUSTO criteria)
• complications related to vascular access of the procedure
• acute kidney failure
• infection
• heart failure

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Related Publications (4)

• 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

• De Luca G, Suryapranata H, van 't Hof AW, de Boer MJ, Hoorntje JC, Dambrink JH, Gosselink AT, Ottervanger JP, Zijlstra F. Prognostic assessment of patients with acute myocardial infarction treated with primary angioplasty: implications for early discharge. Circulation. 2004 Jun 8;109(22):2737-43. doi: 10.1161/01.CIR.0000131765.73959.87. Epub 2004 May 24.

  PMID: 15159293 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

• 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

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Alessandro Sionis, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: June 4, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 4, 2013

Record last verified: 2013-05

Locations

ES (1)