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Prediabetes and Non Obstructive Coronary Atherosclerosis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553030
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Celestino Sardu, University of Campania "Luigi Vanvitelli"

Brief Summary:

Objectives: Prediabetes may condition an early endothelium dysfunction, and the development of non obstructive coronary stenosis (NOCS). Indeed, authors' study aim was to investigate the endothelial dysfunction, and Major Adverse Cardiac Events (MACE) in prediabetics vs. normo glycemic subjects.

Materials and Methods: 308 patients with evidence of left anterior descending (LAD) coronary NOCS (<50% luminal stenosis), will entere prospectively into a database. After assessment of endothelial coronary dysfunction by acetilcoline infusion, 86 propensity score matched (PSM) prediabetics and 86 PSM normoglycemics will be consecutive enrolled in the study.


Condition or disease Intervention/treatment
PreDiabetes Device: coronary artery angiography

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Study Type : Observational
Actual Enrollment : 172 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Early Insurgence of Coronary Artery Dysfunction in Prediabetic Patients With Monovessel Non Obstructive Coronary Stenosis May Condition Major Adverse Cardiac Events at 24 Months of Follow up.
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Group/Cohort Intervention/treatment
prediabetics
patients with diagnosed of prediabetes.
Device: coronary artery angiography
In all patients authors performed a coronary artery angiography for detection of coronary artery stenosis.

normo glycemics (controls)
patients without diagnosed of prediabetes.
Device: coronary artery angiography
In all patients authors performed a coronary artery angiography for detection of coronary artery stenosis.




Primary Outcome Measures :
  1. Major Adverse Cardiac Events (MACE). [ Time Frame: 24 months. ]
    Authors will investigate the MACE, as post procedural and follow up angina, stroke, myocardial infarction, and re-hospitalization for acute coronary syndrome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
a cohort of patients divided in prediabetics (n 86) vs. normoglycemics (n 86) that underwent coronary artery angiography for chest pain.
Criteria

Inclusion Criteria:

  • aged > 18 years.
  • aged < 75 years.
  • monovessel non obstructive coronary stenosis (as stenosis <50% of coronary artery lumen)

Exclusion Criteria:

  • acute coronary syndrome,
  • presence of of both obstructive and non-obstructive stenosis,
  • left ventricular ejection fraction <50%,
  • previous myocardial infarction,
  • previous percutaneous coronary intervention and/or coronary bypass grafting,
  • Tako-tsubo cardiomyopathy,
  • myocarditis,
  • impaired renal function
  • stroke

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): NCT03553030


Locations
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Italy
Raffaele Marfella
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"

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Responsible Party: Celestino Sardu, Principal investigator, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03553030    
Other Study ID Numbers: SecondUNI28.5.2018
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia