Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography

Официальное название

Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography: CORPLAQ-TRAIT Pilot Study

Обзор

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 explore the algorithm's ability to detect the presence of aortic disease and pro-inflammatory cardiometabolic alterations, such as hepatic steatosis and surrogate markers of coronary inflammation.

Подробное описание

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 with a clinical indication to be evaluated by a CCTA due to suspected CAD or known CAD. The study will have a baseline stage in which a clinical evaluation will be performed, blood samples will be drawn for transcriptome analysis and laboratory analysis. Then, a DNA sample obtained by swabbing the buccal mucose will be taken. Subsequently, the images obtained from the clinically indicated CCTA will be assessed to explore the outcomes of interest. At the end of patient enrollment, biological samples will be sequenced for in silico evaluation of the results. Finally, a 5-year follow-up will be carried out via telephone or email contact to collect data on the incidence of fatal and non-fatal cardiovascular events.

Первичные конечные точки

• Coronary calcium score [Срок оценки: At baseline (cross-sectional assessment)]
• Total coronary plaque burden [Срок оценки: At baseline (cross-sectional assesment)]
• Degree of coronary stenosis [Срок оценки: At baseline (cross-sectional assesment)]
• Coronary high-risk plaques (low-attenuation, positive remodeling; spotty calcification, or napkin-ring sign) [Срок оценки: At baseline (cross-sectional assesment)]

Вторичные конечные точки (4)

• Presence and extent of aortic calcification [Срок оценки: At baseline (cross-sectional assessment)]
• Hepatic steatosis [Срок оценки: At baseline (cross-sectional assessment)]
• Coronary artery inflammation (perivascular fat attenuation index) [Срок оценки: At baseline (cross-sectional assessment)]
• Death [Срок оценки: Up to 5 years of Follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Аргентина · 2 центра

• Sanatorio Julio Mendez — Ciudad Autónoma de Buenos Aire
• Clinica Sagrada Familia — Ciudad Autónoma de Buenos Aire

Идентификаторы

NCT: NCT06194526 · ACTC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗