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

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ClinicalTrials.gov Identifier: NCT02940340
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

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.

Condition or disease
Infective Endocarditis

Detailed Description:
This is a cohort study that will include adult patients with active definite infective endocarditis by the modified Duke criteria admitted to our center for treatment. A control group of healthy volunteers, paired by sex and age, will be included. The microcirculatory tests will be performed in an undisturbed quiet room with a defined stable temperature (23 ± 1 °C) after a 20-minute rest in the supine position. Functional capillary density (FCD) defined as the number of spontaneously perfused capillaries per square millimeter of skin area will be assessed by video-microscopy system with an epi-illuminated fiber-optic microscope containing a 100-W mercury vapor lamp light source and an M200 objective with a final magnification of 200×. Images will be acquired and saved for posterior off-line analysis using a semi-automatic integrated system (Micro-vision Instruments, Evry, France). The mean capillary density for each patient will be calculated as the arithmetic mean of visible (i.e., spontaneously perfused) capillaries in three contiguous microscopic fields of 1mm2 each. Capillary recruitment (capillary reserve) will be evaluated using post-occlusive reactive hyperemia (PORH) after arm ischemia for 3 min. Microvascular reactivity will be evaluated using an laser speckle contrast imaging (LSCI) system with a laser wavelength of 785 nm (PeriCam PSI system, Perimed, Sweden) in combination with iontophoresis of acetylcholine (ACh), as an endothelium dependent substance, and nitroprusside (endothelium independent) for noninvasive and continuous measurement of cutaneous microvascular perfusion changes (in arbitrary perfusion units, APU).

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Systemic Microvascular Endothelial Dysfunction in Patients Presenting With Infective Endocarditis Using the Imaging Method of Cutaneous Laser Speckle Flowmetry
Study Start Date : January 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : November 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis




Primary Outcome Measures :
  1. endothelial-dependent and endothelial-independent microvascular reactivity [ Time Frame: two years ]

Secondary Outcome Measures :
  1. systemic capillary density [ Time Frame: two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with infective endocarditis according to Duke criteria
Criteria

Inclusion Criteria: Endocarditis Diagnostic Criteria -- Duke Criteria

  • 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

Exclusion Criteria:

-


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): NCT02940340


Locations
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Brazil
National Institute of Cardiology, Ministry of Health, Brazil
Rio de Janeiro, Brazil, 22240-006
Sponsors and Collaborators
National Institute of Cardiology, Laranjeiras, Brazil
Investigators
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Principal Investigator: Eduardo Tibirica, MD, PhD National Institute of Cardiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eduardo Tibirica, MD, PhD, Senior Researcher, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier: NCT02940340    
Other Study ID Numbers: NICBrazil
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil:
infective endocarditis
systemic microcirculation
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection