Evaluation of Systemic Microvascular Endothelial Dysfunction in Patients Presenting With Infective Endocarditis

NCT02940340 | Completed DMC

• 1 other identifier: NICBrazil
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Infective endocarditis (IE) is a severe clinical condition with a high in-hospital and 5-year mortality. It has a growing incidence, both related to healthcare and possibly to changes in prophylaxis recommendations regarding oral procedures. Though not a new disease, several aspects in its clinical and laboratory diagnosis remain to be better studied and innovated. The evaluation of systemic microvascular disease has proven crucial in the investigation and comprehension of pathophysiology of cardiovascular diseases, as well as a tool for early diagnosis and prediction of complications. Few studies deal with microcirculation in patients with IE, and so far none utilizing speckle contrast imaging and functional capillary density. The present study will contribute to the investigation of microcirculatory changes in IE and possibly to earlier diagnosis of the condition and/or of its severity and complications. The aim of the study is to evaluate the changes in microvascular bed of patients with both acute and subacute endocarditis by speckle contrast imaging and skin video-capillaroscopy.

Conditions

Infective Endocarditis

Keywords

infective endocarditis; systemic microcirculation

Outcome Measures

Primary Outcomes (1)

• endothelial-dependent and endothelial-independent microvascular reactivity

  two years

Secondary Outcomes (1)

• systemic capillary density

  two years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with infective endocarditis according to Duke criteria

You may qualify if:

• Major Diagnostic Criteria
• Positive blood culture for typical Infective Endocarditis organisms (strep viridans or bovis, HACEK, staph aureus without other primary site, enterococcus), from 2 separate blood cultures or 2 positive cultures from samples drawn \> 12 hours apart, or 3 or a majority of 4 separate cultures of blood (first and last sample drawn 1 hour apart)
• Echocardiogram with oscillating intracardiac mass on valve or supporting structures, in the path of regurgitant jets, or on implanted material in the absence of an alternative anatomic explanation, or abscess, or new partial dehiscence of prosthetic valve or new valvular regurgitation
• Minor Diagnostic Criteria
• Predisposing heart condition or intravenous drug use
• Temp \> 38.0° C (100.4° F)
• Vascular phenomena: arterial emboli, pulmonary infarcts, mycotic aneurysms, intracranial bleed, conjunctival hemorrhages, Janeway lesions
• Immunologic phenomena: glomerulonephritis, Osler nodes, Roth spots, rheumatoid factor
• Microbiological evidence: positive blood culture but does not meet a major criterion as noted above or serological evidence of active infection with organism consistent with endocarditis (excluding coag neg staph, and other common contaminants)
• Echocardiographic findings: consistent with endocarditis but do not meet a major criterion as noted above

Sponsors & Collaborators

• National Institute of Cardiology, Laranjeiras, Brazil: lead

Study Sites (1)

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

Location

Related Publications (1)

• Barcelos A, Lamas C, Tibirica E. Evaluation of microvascular endothelial function in patients with infective endocarditis using laser speckle contrast imaging and skin video-capillaroscopy: research proposal of a case control prospective study. BMC Res Notes. 2017 Jul 28;10(1):342. doi: 10.1186/s13104-017-2660-3.

  PMID: 28754178 DERIVED

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Eduardo Tibirica, MD, PhD

  National Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 20, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: November 22, 2017
• Last Updated: November 27, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)