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

NCT05488249 | Unknown

• 1 other identifier: CM-75/2022-COHESIVE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Systemic Inflammatory Response; Chronic Coronary Syndrome; Atherosclerosis

Keywords

coronary vulnerable plaque; CCTA; Systemic inflammation; Coronary shear stress; Plaque topography

Outcome Measures

Primary Outcomes (1)

• Relationship between coronary plaque localization on its degree of vulnerability

  Calculating correlations between analyzed lesion topography (right versus left coronary artery, proximal versus distal vascular localization) and indicators of plaque morphology \*(volume, length, degree of stenosis), plaque composition (calcified, fibrotic, lipid rich volumes), and degree of vulnerability (quantified by the presence of low attenuation plaque, spotty calcium, napkin ring sign, positive remodeling, number of vulnerability markers)

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Relationship between systemic inflammation on coronary plaque vulnerability, according to plaque location and hemodynamic characteristics

  through study completion, an average of 1 year

Interventions

Cardiac imaging tests DIAGNOSTIC_TEST

* 2D transthoracic echocardiography * 128-multislice CT coronary angiography with the evaluation of: epicardial fat volume, plaque burden, total and local calcium score, markers for lesion severity; morphological plaque characteristics; plaque components evaluated via volumetric and planimetric units; markers of plaque vulnerability (necrotic core, low attenuation plaque, spotty calcification, napkin ring sign, positive remodeling). * Shear stress evaluation via computational fluid dynamics.

Venous blood sample collection DIAGNOSTIC_TEST

Venous blood sample collection during CCTA image acquisition for evaluation of serum levels of hsCRP, IL-6, matrix metalloproteases - MMP9, Adhesion molecules (VCAM, ICAM, e-selectin, p-selectin) periostin.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable chest pain who present in out-patient conditions for complete clinical assessment and CCTA evaluation of coronary artery tree, without any history of coronary revascularization, with a low to intermediate pre-test probability for coronary artery disease, who do not present acute or chronic inflammatory/infections disease or malignancy that could interfere with the systemic inflammatory response.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardio Med Medical Center: lead
• George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures: collaborator
• University Hospital of Targu Mures, Romania: collaborator

Study Sites (1)

Cardio Med Medical Center

Târgu Mureş, 540124, Romania

RECRUITING

Related Publications (6)

• Opincariu D, Benedek T, Chitu M, Rat N, Benedek I. From CT to artificial intelligence for complex assessment of plaque-associated risk. Int J Cardiovasc Imaging. 2020 Dec;36(12):2403-2427. doi: 10.1007/s10554-020-01926-1. Epub 2020 Jul 2.

  PMID: 32617720 BACKGROUND

• Opincariu D, Rodean I, Rat N, Hodas R, Benedek I, Benedek T. Systemic Vulnerability, as Expressed by I-CAM and MMP-9 at Presentation, Predicts One Year Outcomes in Patients with Acute Myocardial Infarction-Insights from the VIP Clinical Study. J Clin Med. 2021 Jul 31;10(15):3435. doi: 10.3390/jcm10153435.

  PMID: 34362217 BACKGROUND

• Mester A, Rat N, Benedek T, Opincariu D, Hodas R, Chitu M, Benedek I. Acute-Phase Inflammatory Reaction Predicts CMR Myocardial Scar Pattern and 2-Year Mortality in STEMI Patients Undergoing Primary PCI. J Clin Med. 2022 Feb 24;11(5):1222. doi: 10.3390/jcm11051222.

  PMID: 35268316 BACKGROUND

• Opincariu D, Rat N, Mester A, et al. Site-specific Phenotype of Atherosclerotic Lesions According to Their Location Within the Coronary Tree - a CCTA-based Study of Vulnerable Plaques. Journal of Cardiovascular Emergencies 2021;7(2):39-46. DOI: 10.2478/jce-2021-0010

  BACKGROUND

• DISCHARGE Trial Group; Maurovich-Horvat P, Bosserdt M, Kofoed KF, Rieckmann N, Benedek T, Donnelly P, Rodriguez-Palomares J, Erglis A, Stechovsky C, Sakalyte G, Cemerlic Adic N, Gutberlet M, Dodd JD, Diez I, Davis G, Zimmermann E, Kepka C, Vidakovic R, Francone M, Ilnicka-Suckiel M, Plank F, Knuuti J, Faria R, Schroder S, Berry C, Saba L, Ruzsics B, Kubiak C, Gutierrez-Ibarluzea I, Schultz Hansen K, Muller-Nordhorn J, Merkely B, Knudsen AD, Benedek I, Orr C, Xavier Valente F, Zvaigzne L, Suchanek V, Zajanckauskiene L, Adic F, Woinke M, Hensey M, Lecumberri I, Thwaite E, Laule M, Kruk M, Neskovic AN, Mancone M, Kusmierz D, Feuchtner G, Pietila M, Gama Ribeiro V, Drosch T, Delles C, Matta G, Fisher M, Szilveszter B, Larsen L, Ratiu M, Kelly S, Garcia Del Blanco B, Rubio A, Drobni ZD, Jurlander B, Rodean I, Regan S, Cuellar Calabria H, Boussoussou M, Engstrom T, Hodas R, Napp AE, Haase R, Feger S, Serna-Higuita LM, Neumann K, Dreger H, Rief M, Wieske V, Estrella M, Martus P, Dewey M. CT or Invasive Coronary Angiography in Stable Chest Pain. N Engl J Med. 2022 Apr 28;386(17):1591-1602. doi: 10.1056/NEJMoa2200963. Epub 2022 Mar 4.

  PMID: 35240010 BACKGROUND

• Szilveszter B, Celeng C, Maurovich-Horvat P. Plaque assessment by coronary CT. Int J Cardiovasc Imaging. 2016 Jan;32(1):161-72. doi: 10.1007/s10554-015-0741-8. Epub 2015 Aug 18.

  PMID: 26280890 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood sampling during CCTA image acquisition for evaluation of systemic inflammation (based on hsCRP, interleukin-6, MMP-9, V-CAM, I-CAM, e-selectin, p-selectin, periostin

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Diana Opincariu, MD, PhD

  CardioMed Medical Center

  STUDY DIRECTOR

Central Study Contacts

Diana Opincariu, MD, PhD

CONTACT

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

Theodora Benedek, Professor

CONTACT

+40 265 217 333; theodora.benedek@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 4, 2022
• Study Start: August 5, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The IPD sharing frame is starting 6 months after publication.

Locations

RO (1)