- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02940340
Evaluation of Systemic Microvascular Endothelial Dysfunction in Patients Presenting With Infective Endocarditis
November 22, 2017 updated by: Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
Evaluation of Systemic Microvascular Endothelial Dysfunction in Patients Presenting With Infective Endocarditis Using the Imaging Method of Cutaneous Laser Speckle Flowmetry
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.
Study Overview
Status
Completed
Conditions
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).
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio de Janeiro, Brazil, 22240-006
- National Institute of Cardiology, Ministry of Health, Brazil
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with infective endocarditis according to Duke criteria
Description
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:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
endothelial-dependent and endothelial-independent microvascular reactivity
Time Frame: two years
|
two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
systemic capillary density
Time Frame: two years
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
November 22, 2017
Study Registration Dates
First Submitted
October 19, 2016
First Submitted That Met QC Criteria
October 19, 2016
First Posted (Estimate)
October 20, 2016
Study Record Updates
Last Update Posted (Actual)
November 27, 2017
Last Update Submitted That Met QC Criteria
November 22, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NICBrazil
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infective Endocarditis
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Emil Loldrup FosbolHvidovre University Hospital; Bispebjerg Hospital; Amager Hospital; Herlev and... and other collaboratorsRecruitingEndocarditis InfectiveDenmark, Netherlands, Sweden
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LysovantWithdrawnEndocarditis Infective | Bacteremia Due to Staphylococcus Aureus | Left Sided Infective Endocarditis (Disorder) | Right Sided Infective Endocarditis (Disorder)United States
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Fundacion Clinic per a la Recerca BiomédicaNot yet recruitingEndocarditis InfectiveSpain
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Fondazione Policlinico Universitario Agostino Gemelli...RecruitingEndocarditis InfectiveItaly
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Assistance Publique Hopitaux De MarseilleCompleted
-
Assistance Publique Hopitaux De MarseilleUnknownInfective Endocarditis (IE)France
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Region SkaneCompleted
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Assistance Publique - Hôpitaux de ParisNot yet recruitingProsthetic Valve EndocarditisFrance
-
Assiut UniversityRecruitingProsthetic Valve EndocarditisEgypt
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Montreal Heart InstituteRecruitingInfective Endocarditis | Native Valve EndocarditisCanada