Sao Paulo ST Segment Elevation Myocardial Infarction (STEMI) Registry

NCT02090712 | Unknown

• 1 other identifier: 1838/11
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

At the periphery of the city of São Paulo, in-hospital mortality in acute myocardial infarction is estimated to range between 15% and 20% due to difficulties inherent to delayed answer at a large metropolis. As a city with more than 11 million inhabitants, the distribution of emergency services and public hospitals is also heterogeneous, with scarcity in peripheral zones. That heterogeneity of resources also involves the quality of the medical care provided. The possibility of a standard care with fast transfer after thrombolysis and a tertiary backing system for ECG interpretation, catheterization and advanced support could improve this setting. In a project initiated in 2010, the São Paulo Municipal Health Secretariat, the Federal University of Sao Paulo/Paulista School of Medicine, the Emergency Mobile Health Care Service arranged a planed system of thrombolysis at peripheral hospitals or at the ambulances with immediate transfer to a unique tertiary center for early angiography and angioplasty of the culprit artery. The protocol uses recommendations of Brazilian and international guidelines, and is the same adopted for the management of ST elevation myocardial infarction at Paulista School of Medicine regarding the indications for thrombolytic agents, primary and rescue percutaneous transluminal coronary angioplasty (PTCA), and pharmacoinvasive therapy. The hypothesis of this study is that a network to provide the best care for patients with ST elevation myocardial infarction will reduce mortality rates. The main purpose of this registry is to provide demographics, metrics and results of this experience, maintaining complete records of clinical, laboratory and coronary angiography data of all patients allowing short-term outcome analysis of various variables in a large population. Additionally, follow-up outcomes will be provide in a sub-group of patients keeping their health care at the University or able to be tracked. All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation at different time intervals.

Conditions

Myocardial Infarction

Keywords

myocardial infarction; acute coronary syndrome; coronary disease

Outcome Measures

Primary Outcomes (1)

• Binary MACCE

  All cause death, cerebrovascular event (stroke), documented myocardial infarction, major bleeding, repeat revascularization (PCI or surgery).

  30 days

Secondary Outcomes (6)

• Major Bleeding

  30 days

• MACCE at 1 year

  1 YEAR

• Individual end-points of MACCE

  1 year

• MACCE at 5 years

  5 years

• Congestive Heart Failure (CHF)

  30 days

Other Outcomes (2)

• Cath/PCI

  30 days

• Late clinical follow-up

  1 to 5 years

Study Arms (2)

Reperfusion strategies

Patients submitted to thrombolysis with tenecteplase after acute myocardial infarction will be transferred to a tertiary center and angiography with the intention to treat the culprit artery will be performed in 3 - 48 hours (preferably first 24 hours).

Procedure: PCI

Primary PCI

Patients with contra-indication to thrombolytics or able to reach the catheterization laboratory within 90 minutest will be transferred for primary angioplasty, according to current guidelines.

Procedure: PCI

Interventions

PCI PROCEDURE

Balloon dilatation of the culprit artery followed by stent implantation will be made immediately for patients not receiving thrombolysis or after 3 to 24 hours after thrombolysis, under clinical indication and current practice patterns, in the setting of acute myocardial infarction

Also known as: Coronary angioplasty

Primary PCI; Reperfusion strategies

Eligibility Criteria

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

Study Population

Patients presenting to an emergency room included in the network or being attended by ambulances in this same area, with acute ST segment elevation myocardial infarction will be assesed for thrombolysis (preferable) or primary angioplasty (if within 90' patient would be in the cath lab or when thrombolysis is not possible or contra-indicated) and immediately sent to a tertiary center for catheterization and angioplasty of the culprit artery.

You may qualify if:

• Patients with acute ST segment elevation myocardial infarction diagnosed by the presence of typical symptoms and electrocardiogram (ECG) alterations (either ST segment elevation or presumable new left bundle branch block) within the first 12 hours of symptoms able to receive thrombolysis with tenecteplase (TNK) or to be transferred for primary angioplasty in a tertiary center.

You may not qualify if:

• Age under 18 years-old
• Contra-indication to tenecteplase or any antiplatelet or anticoagulant therapy (mainly due to the presence of factors predisposing to bleeding events).

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Paulista School of Medicine

São Paulo, Brazil

Location

Related Publications (7)

• Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.

  PMID: 23473396 BACKGROUND

• Sousa JMA, Barbosa AHP, Caixeta A, Moraes PIM, Peternelii DG, Ferreira GM, Vanessa E Soufen HN, Gonçalves I, Reggi, S, Moreno CC, Carvalho ACC, Alves CMR. Fatores preditivos de intervenção coronária percutânea de resgate após estratégia fármaco-invasiva em mulheres. Rev Bras Cardiol Invasiva. 2015;23(1):11-15

  BACKGROUND

• Lanaro E, Caixeta A, Soares JA, Alves CM, Barbosa AH, Souza JA, Sousa JM, Amaral A, Ferreira GM, Moreno AC, Junior IG, Stefanini E, Carvalho AC. Influence of gender on the risk of death and adverse events in patients with acute myocardial infarction undergoing pharmacoinvasive strategy. J Thromb Thrombolysis. 2014 Nov;38(4):510-6. doi: 10.1007/s11239-014-1072-7.

  PMID: 24671733 BACKGROUND

• Caluza AC, Barbosa AH, Goncalves I, Oliveira CA, Matos LN, Zeefried C, Moreno AC, Tarkieltaub E, Alves CM, Carvalho AC. ST-Elevation myocardial infarction network: systematization in 205 cases reduced clinical events in the public health care system. Arq Bras Cardiol. 2012 Nov;99(5):1040-8. doi: 10.1590/s0066-782x2012005000100. Epub 2012 Nov 9. English, Portuguese.

  PMID: 23138668 RESULT

• Falcao FJ, Alves CM, Barbosa AH, Caixeta A, Sousa JM, Souza JA, Amaral A, Wilke LC, Perez FC, Goncalves Junior I, Stefanini E, Carvalho AC. Predictors of in-hospital mortality in patients with ST-segment elevation myocardial infarction undergoing pharmacoinvasive treatment. Clinics (Sao Paulo). 2013 Dec;68(12):1516-20. doi: 10.6061/clinics/2013(12)07.

  PMID: 24473509 RESULT

• Gomes Junior MPM, Falcao FJA, Alves CMR, Sousa JMA, Herrmann JL, Moreno ACC, et al. Vascular complications in patients undergoing early percutaneous coronary intervention via the femoral artery after fibrinolysis with tenecteplase: registry of 199 patients Rev Bras Cardiol Invasiva. 2012;20(3):274-81, http://dx.doi.org/10.1590/S2179-83972012000300010.

  RESULT

• De Marqui Moraes PI, Galhardo A, Barbosa AHP, de Sousa JMA, Alves CMR, Bianco HT, Dos Santos Povoa RM, Stefanini E, Goncalves I Jr, de Almeida DR, Fonseca FAH, de Oliveira Izar MC, Moises VA, Lopes RD, Carvalho AC, Caixeta A. Metrics of care and cardiovascular outcomes in patients with ST-elevation myocardial infarction treated with pharmacoinvasive strategy: a decade-long network in a populous city in Brazil. BMC Cardiovasc Disord. 2023 Jun 15;23(1):300. doi: 10.1186/s12872-023-03340-6.

  PMID: 37322425 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Coronary Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Iran Gonçalves Jr, m.d., Phd

  Assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor - Department of Cardiology

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 18, 2014
• Study Start: January 1, 2010
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

BR (1)