Analysis of the Microbiota and STEMI

NCT03439592 | Completed

• 1 other identifier: 142002018
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperglycemia is a common finding in patients diagnosed with acute coronary syndrome (ACS), and an independent predictor of mortality in patients with and without diabetes. Though percutaneous coronary intervention (PCI) is the cornerstone of ST-segment elevation myocardial infarction (STEMI), the incidence of heart failure, re-infarction and death in hyperglycemic patients remains significant, with a mortality of more than 40% one year after the event. In these STEMI patients dual anti-aggregation therapy is currently the gold standard after PCI, but bleeding phenomena, and therapeutic resistance may reduce their therapeutic efficacy. Therefore, it is likely that the individual response to the dual anti-aggregation therapy, and the hyperglycemic stress, may influence resistance mechanisms, and/or lead to an increase in pharmacological functional deactivation by the microbiotic flora. The term microbiota indicates the totality of the genomes of microorganisms that reside in an ecological niche, and which constitute the "human microbiota". In this context, the analysis of the faecal microbiota before PCI, at hospital discharge and at follow-up, could be considered useful for identifying hyperglycaemic patients with alteration of metabolic-oxidative processes, and pro-thrombotic correlates with worse post procedural prognosis. Therefore, the analysis of faecal microbiota during the STEMI event could theoretically identify hyperglycemic patients with excessive inflammatory and oxidative tone caused by hyperglycemia, conditioning resistance to double anti-aggregation therapy and coronary stenting, and conditioning pro-thrombotic phenomena after coronary reperfusion by PCI. Therefore, authors will conduct a study to analyze the microbiota in patients with acute hyperglycaemic and normoglycemic coronary syndrome. The primary objective of this study will be to evaluate any changes in the microbiota and its activity on faecal material taken before PCI, and after 6 and 12 months in patients with hyperglycemic STEMI, and also evaluate if the changes in the microbiota can be related to the 12-month prognosis.

Conditions

STEMI; Diabetes Mellitus; Microbial Colonization

Outcome Measures

Primary Outcomes (2)

• all cause deaths

  authors will evaluate form hospital discharge schedules, and during follow up by clinical visits the deaths events for all causes.

  12 months

• cardiac deaths

  authors will evaluate form hospital discharge schedules, and during follow up by clinical visits the deaths events for cardiac causes.

  12 months

Study Arms (2)

hyperglycemic patients

diabetic patients admitted for STEMI and with hyperglycemia at hospital admission.

Diagnostic Test: collection of fecal material

normoglycemic patients

diabetic patients admitted for STEMI and with normoglycemia at hospital admission.

Diagnostic Test: collection of fecal material

Interventions

collection of fecal material DIAGNOSTIC_TEST

in study population we will collect fecal material to analyze the microbiotic flora by genetic techniques.

hyperglycemic patients; normoglycemic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with hyperglycemic STEMI v/s normoglycemic STEMI. All patients with onset of symptoms within 12 hours and 1 mm elevation of the ST segment in 2 or more contiguous peripheral leads or at least 2 mm in 2 or more contiguous precordial leads or new onset left branch block will be considered for percutaneous coronary intervention (PCI). Patients aged over 18 and admitted for first STEMI episode.

You may qualify if:

• aged \> 18 years
• STEMI acute admission event

You may not qualify if:

• left ventricular ejection fraction \<25%,
• previous acute myocardial infarction
• previous percutaneous coronary intervention
• previous coronary artery by-pass

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Raffaele Marfella

Naples, 80138, Italy

Location

Related Publications (3)

• Deedwania P, Kosiborod M, Barrett E, Ceriello A, Isley W, Mazzone T, Raskin P; American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Hyperglycemia and acute coronary syndrome: a scientific statement from the American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2008 Mar 25;117(12):1610-9. doi: 10.1161/CIRCULATIONAHA.107.188629. Epub 2008 Feb 25.

  PMID: 18299505 RESULT

• Sardu C, Consiglia Trotta M, Santella B, D'Onofrio N, Barbieri M, Rizzo MR, Sasso FC, Scisciola L, Turriziani F, Torella M, Portoghese M, Loreni F, Mureddu S, Lepore MA, Galdiero M, Franci G, Folliero V, Petrillo A, Boatti L, Minicucci F, Mauro C, Calabro P, Feo M, Balestrieri ML, Ercolini D, D'Amico M, Paolisso G, Galdiero M, Marfella R. Microbiota thrombus colonization may influence athero-thrombosis in hyperglycemic patients with ST segment elevation myocardialinfarction (STEMI). Marianella study. Diabetes Res Clin Pract. 2021 Mar;173:108670. doi: 10.1016/j.diabres.2021.108670. Epub 2021 Jan 14.

  PMID: 33453294 DERIVED

• Sardu C, Pieretti G, D'Onofrio N, Ciccarelli F, Paolisso P, Passavanti MB, Marfella R, Cioffi M, Mone P, Dalise AM, Ferraraccio F, Panarese I, Gambardella A, Passariello N, Rizzo MR, Balestrieri ML, Nicoletti G, Barbieri M. Inflammatory Cytokines and SIRT1 Levels in Subcutaneous Abdominal Fat: Relationship With Cardiac Performance in Overweight Pre-diabetics Patients. Front Physiol. 2018 Aug 21;9:1030. doi: 10.3389/fphys.2018.01030. eCollection 2018.

  PMID: 30246793 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

we will collect fecal material obtained before, and during percutaneous coronary intervention in STEMI patients.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Diabetes Mellitus; Communicable Diseases

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections; Disease Attributes

Study Officials

• raffaele marfella, MD, PhD

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 20, 2018
• Study Start: January 1, 2016
• Primary Completion: September 30, 2020
• Study Completion: June 1, 2021
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)