UnknownNot Applicable

CCTA Coronary Hemodynamics, Systemic Inflammation and Vulnerable Plaques (COHESIVE)

Romania100 participantsStarted 2022-08-05

Plain-language summary

Although there are numerous studies that have demonstrated the impact of systemic inflammation on coronary plaque vulnerability, there are few literature data regarding the influence of coronary plaque localization within the coronary tree (right and left coronary artery, proximal, mid-coronary and distal), on plaque composition, morphology and degree of vulnerability, in relation with systemic inflammation and coronary hemodynamics. The aim of this study is to identify: (1) the impact of plaque topography in different sites within the coronary tree (right versus left, proximal distal) on their vulnerability degree evaluated with CCTA; (2) the relationship between degree of plaque vulnerability, systemic inflammatory biomarkers and specific hemodynamic characteristics quantified by coronary shear stress computations. The study will include 100 patients with stable coronary artery disease for which data collection will be perform on: (1) Clinical, echocardiographic and ECG data; (2) cardiovascular risk assessment; (3) 128 slice CCTA evaluation of coronary tree anatomy, plaque morphology, composition and vulnerability degree; (4) systemic inflammation based on serum levels of hsCRP, IL-6, MMP-9, periostin, adhesion molecules (5) shear stress via coronary flow computational simulations.

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * chronic coronary syndromes (defined according to current ESC guidelines) presenting in out-patient conditions for CCTA evaluation of stable chest pain * age over 30 years Exclusion Criteria: * the presence of acute coronary syndromes at the moment of enrollment * the presence of coronary stents and severe calcifications or other conditions that could interfere with image postprocessing and coronary plaque analysis * acute renal failure of end-stage chronic kidney disease * contraindication for iodine contrast agent administration (allergies, thyroid dysfunction, etc) * active malignancy or history of cancer within the last 12 months prior to enrollment. * systemic inflammatory disease, acute infections, positive SARS-CoV2 test, or other conditions that could interfere with the systemic inflammatory response.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relationship between coronary plaque localization on its degree of vulnerability

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05488249

SponsorCardio Med Medical Center

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-08

Contact for this trial

Diana Opincariu, MD, PhD

+40 265 217 333 diana.opincariu@yahoo.ro

View on ClinicalTrials.gov More Coronary Artery Disease trials