Quality and Safety of Initial Management for ST-segment Elevation Myocardial Infarction

NCT02788344 | Completed DMC

• 1 other identifier: PREPS14-0040
• Study Type: observational
• Target: 6,920
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter multidisciplinary study designed to investigate patient, provider, and system-related factors that are associated with the quality and safety of initial management for suspected ST-segment elevation myocardial infarction (STEMI) evolving for less than 12 hours in daily practice. The primary hypotheses are that delayed reperfusion therapy for suspected STEMI independently relates to provider practice patterns and system barriers. It is further postulated that non-compliance with target delays in implementing percutaneous coronary intervention (PCI) or fibrinolytic therapy is associated with worse in-hospital clinical outcomes. The secondary hypotheses are that the delivery of acute reperfusion therapy within target delays is associated with increased rates of false-positive cardiac catheterization laboratory activation, inadvertent fibrinolytic therapy, and bleeding events. The project will be conducted in three emergency medical services and 23 public and private (for-profit and non-for-profit) acute care hospitals in Northern Alps in France. Data over the index hospital stay period will be retrospectively collected for all the patients included in an ongoing prospective regional hospital-based clinical registry of suspected STEMI from October, 1st, 2002 to December, 31, 2014. Inclusion of 7435 patients is anticipated. In this observational retrospective study, no specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. No enrollment or follow-up visits are planned. The primary effectiveness outcome is timely acute reperfusion therapy. The secondary effectiveness outcomes include false-positive cardiac catheterization laboratory activation for catheterization candidates and inadvertent fibrinolytic therapy. The secondary medical outcomes include in-hospital all-cause mortality, major adverse cardiovascular events, and major bleeding events. Multivariable logistic regression model will be developed to identify baseline characteristics that are independently associated with timely acute reperfusion therapy. Propensity score analysis will be performed for comparing clinical outcomes between timely acute reperfusion therapy recipients and non-recipients.

Conditions

Myocardial Infarction

Keywords

Observational study; Myocardial revascularization; Thrombolytic therapy; Hospital mortality; Hemorrhage; Quality of health care; Angioplasty

Outcome Measures

Primary Outcomes (3)

• Fibrinolytic therapy within 30 minutes of first medical contact

  30 minutes

• primary PCI within 60 minutes for early presenters or patients, presenting directly to a PCI capable hospital

  60 minutes

• primary PCI within 90 minutes of first medical contact for all patients

  90 minutes

Secondary Outcomes (3)

• In-hospital all-cause mortality

  up to 2 weeks, from the day of myocardial infarction's onset to the first hospital discharge

• In-hospital major adverse cardiovascular events (reinfarction, cardiogenic shock, heat failure, stroke, cardiac arrest)

  up to 2 weeks, from the day of myocardial infarction's onset to the first hospital discharge

• In-hospital major bleeding events

  up to 2 weeks, from the day of myocardial infarction's onset to the first hospital discharge

Interventions

Daily practice care for patients with suspected of STEMI OTHER

N/A: Practice care evaluation in real-life setting

Eligibility Criteria

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

Study Population

Patients 18 years of age or older with symptoms suggestive of myocardial infarction (chest pain lasting for more than 20 minutes and not responsive to nitrates). Eligible patients are enrolled irrespective of final discharge diagnosis of STEMI, other acute coronary syndrome (non-ST-segment elevation myocardial infarction, unstable angina pectoris), other cardiac disease, or non-cardiac disease.

You may qualify if:

• patients 18 years of age or older
• who are alive at first medical contact
• with symptoms suggestive of myocardial infarction (chest pain lasting for more than 20 minutes and not responsive to nitrates),
• occuring between October, 1st, 2002 and December, 31, 2014
• evolving for less than 12 hours from symptom onset,
• and with evidence of persistent ST-segment elevation of at least 1 mm in two or more limb leads, ST-segment elevation of at least 2 mm in two or more precordial leads, or new or presumed new left bundle branch block.

You may not qualify if:

• patients who refused the use of their medical data
• patient already hospitalized when STEMI occured, whatever the reason of hospitalization

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead
• University Hospital, Grenoble: collaborator

Study Sites (1)

RENAU network

Metz-Tessy, 74374, France

Location

Related Publications (9)

• Belle L, Fourny M, Reynaud T, Hammer L, Vanzetto G, Labarere J; RENAU-RESURCOR study investigators. Efficacy and safety of glycoprotein IIb/IIIa receptor antagonists for patients undergoing percutaneous coronary intervention within twelve hours of fibrinolysis. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):376-84. doi: 10.1002/ccd.22825. Epub 2011 Mar 16.

  PMID: 21413113 BACKGROUND

• Belle L, Labarere J, Fourny M, Drouet E, Mulak G, Dujardin JJ, Vilarem D, Bonnet P, Hanssen M, Simon T, Ferrieres J, Danchin N; French registry of Acute ST elevation or non-ST-elevation Myocardial Infarction study investigators. Quality of care for myocardial infarction at academic and nonacademic hospitals. Am J Med. 2012 Apr;125(4):365-73. doi: 10.1016/j.amjmed.2011.11.015.

  PMID: 22444102 BACKGROUND

• Belle L, Motreff P, Mangin L, Range G, Marcaggi X, Marie A, Ferrier N, Dubreuil O, Zemour G, Souteyrand G, Caussin C, Amabile N, Isaaz K, Dauphin R, Koning R, Robin C, Faurie B, Bonello L, Champin S, Delhaye C, Cuilleret F, Mewton N, Genty C, Viallon M, Bosson JL, Croisille P; MIMI Investigators*. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388.

  PMID: 26957418 BACKGROUND

• Beygui F, Cayla G, Roule V, Roubille F, Delarche N, Silvain J, Van Belle E, Belle L, Galinier M, Motreff P, Cornillet L, Collet JP, Furber A, Goldstein P, Ecollan P, Legallois D, Lebon A, Rousseau H, Machecourt J, Zannad F, Vicaut E, Montalescot G; ALBATROSS Investigators. Early Aldosterone Blockade in Acute Myocardial Infarction: The ALBATROSS Randomized Clinical Trial. J Am Coll Cardiol. 2016 Apr 26;67(16):1917-27. doi: 10.1016/j.jacc.2016.02.033.

  PMID: 27102506 BACKGROUND

• Fourny M, Lucas AS, Belle L, Debaty G, Casez P, Bouvaist H, Francois P, Vanzetto G, Labarere J. Inappropriate dispatcher decision for emergency medical service users with acute myocardial infarction. Am J Emerg Med. 2011 Jan;29(1):37-42. doi: 10.1016/j.ajem.2009.07.008. Epub 2010 Mar 9.

  PMID: 20825772 BACKGROUND

• Labarere J, Belle L, Fourny M, Vanzetto G, Debaty G, Delgado D, Brallet J, Vallet B, Danchin N; USIC 2000; FAST-MI. Regional system of care for ST-segment elevation myocardial infarction in the Northern Alps: a controlled pre- and postintervention study. Arch Cardiovasc Dis. 2012 Aug-Sep;105(8-9):414-23. doi: 10.1016/j.acvd.2012.05.001. Epub 2012 Jul 17.

  PMID: 22958884 BACKGROUND

• Labarere J, Belle L, Fourny M, Genes N, Lablanche JM, Blanchard D, Cambou JP, Danchin N; Unite de Soins Intendifs Coronaires 2000 Inverstigators. Outcomes of myocardial infarction in hospitals with percutaneous coronary intervention facilities. Arch Intern Med. 2007 May 14;167(9):913-20. doi: 10.1001/archinte.167.9.913.

  PMID: 17502532 BACKGROUND

• Raskovalova T, Twerenbold R, Collinson PO, Keller T, Bouvaist H, Folli C, Giavarina D, Lotze U, Eggers KM, Dupuy AM, Chenevier-Gobeaux C, Meune C, Maisel A, Mueller C, Labarere J. Diagnostic accuracy of combined cardiac troponin and copeptin assessment for early rule-out of myocardial infarction: a systematic review and meta-analysis. Eur Heart J Acute Cardiovasc Care. 2014 Mar;3(1):18-27. doi: 10.1177/2048872613514015. Epub 2013 Nov 20.

  PMID: 24562800 BACKGROUND

• Yayehd K, Ricard C, Ageron FX, Buscaglia L, Savary D, Audema B, Lacroix D, Barthes M, Joubert P, Gheno G, Belle L; RENAU-RESURCOR study investigators. Role of primary care physicians in treating patients with ST-segment elevation myocardial infarction located in remote areas (from the REseau Nord-Alpin des Urgences [RENAU], Network). Eur Heart J Acute Cardiovasc Care. 2015 Feb;4(1):41-50. doi: 10.1177/2048872614544856. Epub 2014 Jul 29.

  PMID: 25075005 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Loïc E BELLE, MD

  CH Annecy Genevois, head of RENAU (Réseau Nord Alpin des Urgences)

  STUDY CHAIR

• José LABARERE, MD, PhD

  Centre Hospitalier Universitaire Grenoble Alpes, France

  STUDY CHAIR

• Gérald VANZETTO, MD, PhD

  Centre Hospitalier Universitaire Grenoble Alpes, France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 2, 2016
• Study Start: May 15, 2017
• Primary Completion: May 31, 2017
• Study Completion: June 15, 2017
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

FR (1)