A Non-interventional, Prospective, Cross-sectional Study of Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Sars-Cov-2

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

Pneumonia, which can be acquired in the community (including influenza and COVID-19), is a leading cause of mortality. The risk of severe cardiovascular diseases events (stroke, myocardial infarction, pulmonary embolism) increases after infections, but causal mechanisms are not understood yet. There is an essential need for improved understanding of the relationship between pneumonia and cardiovascular diseases and early identification of patients at risk of cardiovascular events to develop tailored therapies. The overall concept underpinning Homi-lung is to investigate the time course of host-microbiome interactions during \& after pneumonia to i) understand the causal relationship between trained immunity, microbiome dysbiosis and cardiovascular and respiratory diseases (CVRD) progressions, ii) define endotypes of pneumonia associated with response to treatment \& CVRD history; iii) develop biomarkers to predict the individual response to the treatment \& CVRD progression, and iv) preclinically validate therapeutical approaches for CVRD during \& after pneumonia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ Group A (healthy controls)

• Adults (18 years or more) of both genders (Female/Male: 50/50 ratio)

• No history of severe pneumonia (sCAP, COVID-19 or HAP)

• Presence of no or one of the following comorbidities: obesity (defined as body mass index over 35 kg/m2), type 2 diabetes mellitus, hypercholesterolemia, essential arterial hypertension, or familial history of CVD.

⁃ Group B (CVRD controls)

• Adults (18 years or more) of both genders (Female/Male ratio: 50/50)

• No history of severe pneumonia (sCAP, COVID-19 or HAP)

• At least two of the following comorbidities: obesity (defined as body mass index over 35 kg/m2), type 2 diabetes mellitus, hypercholesterolemia, essential arterial hypertension, or familial history of CVD

⁃ Group C (COVID-19 survivors)

• Adults (18 years or more) of both genders (Female/Male ratio: 50/50)

• Survivors from severe COVID-19 pneumonia at hospital discharge; all patients had consolidation in chest X-ray or chest computed tomography during acute infection and were treated for pneumonia

• SoC treatment for acute COVID-19 with dexamethasone

⁃ Group D (sCAP survivors)

• Adults (18 years or more) of both genders

• Survivors from sCAP pneumonia; these patients may be either hospitalized in the ward with pO2FiO2 ratio less than 300 or require admission and hospitalization in the Intensive Care Unit.

• SoC treatment for sCAP with antibiotics

Locations
Other Locations
Greece
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
NOT_YET_RECRUITING
Alexandroupoli
10th Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
RECRUITING
Athens
1st Department of Internal Medicine, General Hospital of Athens G. GENNIMATAS
NOT_YET_RECRUITING
Athens
1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.
RECRUITING
Athens
1st Department of Internal Medicine, General Hospital of Voula ASKLEPIEIO
RECRUITING
Athens
1st Intensive Care Clinic of the Medical School of the University of Athens, Evangelismos General Hospital
NOT_YET_RECRUITING
Athens
1st University Department of Internal Medicine, General Hospital of Athens LAIKO
RECRUITING
Athens
1st University Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
RECRUITING
Athens
2nd Department of Pulmonary Medicine, Sotiria Athens Hospital of Chest Diseases
NOT_YET_RECRUITING
Athens
3rd University Department of Internal Medicine, Sotiria Athens Hospital of Chest Diseases
RECRUITING
Athens
4th Department of Internal Medicine, ATTIKON University General Hospital
RECRUITING
Athens
Intensive Care Unit, General Hospital of Voula ASKLEPIEIO
RECRUITING
Athens
Out-patients clinic, General Hospital of Voula ASKLEPIEIO
RECRUITING
Athens
1st Department of Internal Medicine, Thriasio General Hospital of Elefsina
NOT_YET_RECRUITING
Elefsina
Intensive Care Unit 2, AHEPA University General Hospital of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
Intensive Care Unit, Ippokrateion General Hospital of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
Contact Information
Primary
Prof. Evangelos Giamarellos-Bourboulis
egiamarel@med.uoa.gr
00302105831994
Time Frame
Start Date: 2024-11-08
Estimated Completion Date: 2028-06-08
Participants
Target number of participants: 650
Treatments
Healthy controls
Controls with no or one comorbidity, predisposing to significant CV events and without a medical history of severe pneumonia.
CVRD controls
Controls with comorbidities predisposing to major CV events and without a medical history of severe pneumonia
COVID-19 survivors
Patients cured of acute COVID-19
sCAP survivors
Patients cured of severe community-acquired pneumonia
Sponsors
Leads: Hellenic Institute for the Study of Sepsis

This content was sourced from clinicaltrials.gov