NCT03439592

Analysis of the Microbiota and STEMI

Status unknown Last updated 6 October 2020

What this trial tests

trial testing collection of fecal material in STEMI in 200 participants. Status unknown.

Timeline

1 January 2016

Primary endpoint
30 September 2020

1 June 2021

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	1 January 2016
Primary completion	30 September 2020
Estimated completion	1 June 2021
Sites	1 location across Italy

Drugs / interventions tested

• collection of fecal material

Conditions studied

• STEMI — all drugs for STEMI →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Microbial Colonization — all drugs for Microbial Colonization →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

18 and older, any sex, with STEMI or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The sirtuin family in health and disease.
   Wu QJ, Zhang TN, Chen HH, Yu XF, et al · · 2022 · cited 583× · PMID 36581622 · DOI 10.1038/s41392-022-01257-8
2. Inflammatory Cytokines and SIRT1 Levels in Subcutaneous Abdominal Fat: Relationship With Cardiac Performance in Overweight Pre-diabetics Patients.
   Sardu C, Pieretti G, D'Onofrio N, Ciccarelli F, et al · · 2018 · cited 50× · PMID 30246793 · DOI 10.3389/fphys.2018.01030
3. Microbiota thrombus colonization may influence athero-thrombosis in hyperglycemic patients with ST segment elevation myocardialinfarction (STEMI). Marianella study.
   Sardu C, Consiglia Trotta M, Santella B, D'Onofrio N, et al · · 2021 · cited 25× · PMID 33453294 · DOI 10.1016/j.diabres.2021.108670