Status:
ENROLLING_BY_INVITATION
Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography
Lead Sponsor:
MultiplAI Health Limited
Collaborating Sponsors:
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
Conditions:
Calcific Coronary Arteriosclerosis
Coronary Stenosis
Eligibility:
All Genders
18-75 years
Brief Summary
The present clinical study aims to identify transcriptomic patterns derived from whole blood samples related to coronary atherotic burden. Additionally, as a secondary analysis, the research team will...
Detailed Description
This will be a prospective observational study. A convenience sample will be carried out to include 200 patients who attend the ENERI Medical Institute, La Sagrada Familia Clinic and Sanatorio Mendez ...
Eligibility Criteria
Inclusion
- Men and women between 18 and 75 years, with a clinical indication to be evaluated by a CCTA due to suspected or known CAD.
- Signature of informed consent.
Exclusion
- Previously known chronic renal or hepatic insufficiency.
- Active chronic lung disease, defined as: exacerbated asthma, exacerbated COPD, or pulmonary fibrosis.
- Myocardial infarction, unstable angina, cerebrovascular accident, or vascular interventions (any territory) in the past 6 months.
- Implantation of drug-eluting stents in the last 12 months.
- Revascularization surgery (By-pass)
- Indication of Angio-CT for congenital heart disease or Transcatheter Aortic Valve Replacement (TAVI)
- Presence/ diagnosis of heart failure symptoms or signs (ie. dyspnea, asthenia, edema) with objective evidence of pulmonary or systemic congestion at rest or with exercise in the last 6 months.
- Left ventricular ejection fraction \<50% confirmed by objective diagnostic methods (eg doppler echocardiogram).
- Severe valvulopathies, confirmed by objective diagnostic methods (eg doppler echocardiogram).
- Uncontrolled hyper or hypothyroidism.
- Suprarenal insufficiency.
- Previous surgeries in the last 3 months.
- Severe trauma in the last 6 months, defined as one that involved bone fractures and/or surgical interventions.
- Known active cancer disease or under treatment (acute or preventive), or history of cancer disease without criteria for cure.
- Diagnosis of active autoimmune disease or any pathology under immunosuppressive treatment.
- Ongoing pregnancy, postpartum period of less than 12 months or breastfeeding.
- Other serious diseases with an estimated life expectancy of less than 12 months (according to the investigator's opinion).
- Temperature greater than 37.5°C recorded by a thermometer or any acute infection caused by viruses or bacteria confirmed by a health professional in the previous 30 days.
- Pacemaker/Cardio-Defibrillator Implantation.
- Prior to the study: heart rate \> 70 l/m or atrial fibrillation or frequent extrasystoles that in the opinion of the specialist physician will affect the quality of the cardiovascular imaging.
Key Trial Info
Start Date :
September 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06194526
Start Date
September 19 2023
End Date
September 1 2028
Last Update
January 8 2024
Active Locations (2)
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1
Sanatorio Julio Mendez
Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., Argentina, 1405
2
Clinica Sagrada Familia
Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., Argentina, 1425