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Analysis of the Microbiota and STEMI

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ClinicalTrials.gov Identifier: NCT03439592
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Celestino Sardu, University of Campania "Luigi Vanvitelli"

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.

Condition or disease Intervention/treatment
STEMI Diabetes Mellitus Microbial Colonization Diagnostic Test: collection of fecal material

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Microbiota in Hyperglycemic and Normoglycemic Patients With ST Segment Elevation Myocardial Infarction (STEMI)
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort Intervention/treatment
hyperglycemic patients
diabetic patients admitted for STEMI and with hyperglycemia at hospital admission.
Diagnostic Test: collection of fecal material
in study population we will collect fecal material to analyze the microbiotic flora by genetic techniques.

normoglycemic patients
diabetic patients admitted for STEMI and with normoglycemia at hospital admission.
Diagnostic Test: collection of fecal material
in study population we will collect fecal material to analyze the microbiotic flora by genetic techniques.




Primary Outcome Measures :
  1. all cause deaths [ Time Frame: 12 months ]
    authors will evaluate form hospital discharge schedules, and during follow up by clinical visits the deaths events for all causes.

  2. cardiac deaths [ Time Frame: 12 months ]
    authors will evaluate form hospital discharge schedules, and during follow up by clinical visits the deaths events for cardiac causes.


Biospecimen Retention:   Samples With DNA
we will collect fecal material obtained before, and during percutaneous coronary intervention in STEMI patients.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • aged > 18 years
  • STEMI acute admission event

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439592


Contacts
Contact: Raffaele Marfella, MD, PhD +39 0815665110 raffaele.marfella@unicampania.it
Contact: Celestino Sardu, MD, MSc, PhD +39 3336664543 drsarducele@gmail.com

Locations
Italy
Raffaele Marfella Recruiting
Naples, Italy, 80138
Contact: Raffaele Marfella, MD, PhD    +39 0810815665110    raffaele.marfella@unicampania.it   
Contact: Celestino Sardu, MD, MSc, PhD    +393336664543    drsarducele@gmail.com   
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
Study Chair: raffaele marfella, MD, PhD University of Campania "Luigi Vanvitelli"

Publications of Results:
Responsible Party: Celestino Sardu, assistant professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03439592     History of Changes
Other Study ID Numbers: 142002018
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Communicable Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Diabetes Mellitus
ST Elevation Myocardial Infarction
Infection
Myocardial Infarction
Myocardial Ischemia