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Calcific Coronary ArteriosclerosisCORPLAQ-TRAITNCT06194526

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

An observational study of Calcific Coronary Arteriosclerosis and Coronary Stenosis, run by MultiplAI Health Limited at 2 sites in Argentina.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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 explore the algorithm's ability to detect the presence of aortic disease and pro-inflammatory cardiometabolic… Read more about this study

Who is it for?
Ages 18 to 75 years
How many people
200 participants
Where
2 sitesArgentina
Study dates
19 Sep 2023to Sep 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 200 Men and Women between 18 and 75 years of age with a physician's indication of a CCTA evaluation due to suspected or known CAD.

Who may be able to join

  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Argentina2 sites

  • Sanatorio Julio Mendez

    Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., 1405

  • Clinica Sagrada Familia

    Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., 1425

Other trials in Argentina

About this study

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

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.

Read the 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 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.

Keywords
risk stratification, CVD screening, general population, transcriptomics, primary prevention, artificial intelligence, no history of CVD & history of CVD, subclinical, inflammation
Medical subject headings
Coronary Stenosis, Plaque, Atherosclerotic, Inflammation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coronary calcium score

    Coronary artery calcium (CAC) score (Agatston units) stratified with increasing risk according to the Society of Cardiovascular Computed Tomography Guidelines as CAC=0; CAC 1-99; CAC 100-299; and CAC≥300.

    Measured: At baseline (cross-sectional assessment)

  2. Total coronary plaque burden

    The extension of atherosclerotic disease burden will be assessed using the Modified Duke prognostic CAD index as follows: 1) ,50% stenosis; (2) ≥2 non-obstructive stenoses (including one artery with proximal disease or one artery with 50-69% stenosis); (3) two vessels with stenoses 50-69% or one vessel with ≥70% stenosis; (4) three-vessel disease with stenoses 50-69%, or two vessels ≥70%, or proximal LAD stenosis ≥70%; (5) three-vessel disease with stenoses ≥70% or two-vessel disease ≥70% with proximal LAD; (6) left main stenosis ≥50%.

    Measured: At baseline (cross-sectional assesment)

  3. Degree of coronary stenosis

    Each coronary segment will be graded based on the degree of coronary stenosis as 0% (no visible stenosis), 1-24% (minimal stenosis); 25-49% (mild stenosis); 50-69% (moderate stenosis); 70-99% (severe stenosis); 100% (occluded).

    Measured: At baseline (cross-sectional assesment)

  4. Coronary high-risk plaques (low-attenuation, positive remodeling; spotty calcification, or napkin-ring sign)

    Presence of any of the following features: low-attenuation (average density equal or lower than 30 Hounsfield units), positive remodeling (remodeling index equal or higher than 1.1; spotty calcification (average density >130 HU, diameter <3 mm in any direction with the length of the calcium <1.5 times the vessel diameter and width of the calcification less than two-thirds of the vessel diameter), or napkin-ring sign (ring-like attenuation pattern with peripheral high attenuation tissue that surrounds a central lower attenuation portion).

    Measured: At baseline (cross-sectional assesment)

Secondary outcomes (4)

  1. Presence and extent of aortic calcification

    Aortic valve calcification score (Agatston units) as a continuous variable with increasing risk and without preestablished thresholds (ranging from 0 to 5.000 Agatston units).

    Measured: At baseline (cross-sectional assessment)

  2. Hepatic steatosis

    Defined as liver attenuation level lower than 48 Hounsfield units (HU), and lower than than the spleen attenuation.

    Measured: At baseline (cross-sectional assessment)

  3. Coronary artery inflammation (perivascular fat attenuation index)

    This secondary analysis will be performed using using specific software.

    Measured: At baseline (cross-sectional assessment)

  4. Death

    Death

    Measured: Up to 5 years of Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2024
  2. Study start19 Sep 2023
  3. Primary completionAug 2024 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06194526
Sponsor's protocol ID
ACTC
Acronym
CORPLAQ-TRAIT
Status last verified
Jan 2024
First submitted
31 Oct 2023
Last updated
8 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Calcific Coronary Arteriosclerosis and Coronary Stenosis, run by MultiplAI Health Limited at 2 sites in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary calcium score (time frame: At baseline (cross-sectional assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06194526.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.

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