NCT06194526Enrolling by invitation
Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography
Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography: CORPLAQ-TRAIT Pilot Study
Source: ClinicalTrials.gov · Last updated 8 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 31 Oct 2023
- Start date
- 19 Sept 2023
- Primary completion date
- Aug 2024
- Lead sponsor
- MultiplAI Health Limited
- Diseases
- Coronary artery disease
- NCT number
- NCT06194526
What you commit to
- Study type: Observational
- Planned participants: 200
- From 19 Sept 2023 to the primary completion date, Aug 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously known chronic renal or hepatic insufficiency.
- Implantation of drug-eluting stents in the last 12 months.
- Revascularization surgery (By-pass)
- 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.
- 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.
- 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.
Other illness
- 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.
- 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.
- Suprarenal insufficiency.
- 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.
- Other serious diseases with an estimated life expectancy of less than 12 months (according to the investigator's opinion).
Lab values
- Left ventricular ejection fraction \<50% confirmed by objective diagnostic methods (eg doppler echocardiogram).
Other
- Severe valvulopathies, confirmed by objective diagnostic methods (eg doppler echocardiogram).
- Uncontrolled hyper or hypothyroidism.
- Ongoing pregnancy, postpartum period of less than 12 months or breastfeeding.
- Pacemaker/Cardio-Defibrillator Implantation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Sagrada Familia Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aire | Argentina | Unknown status |
| Sanatorio Julio Mendez Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aire | Argentina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.