Coronary Artery DiseaseCOHESIVENCT05488249
CCTA Coronary Hemodynamics, Systemic Inflammation and Vulnerable Plaques (COHESIVE)
An observational study of Coronary Artery Disease and Systemic Inflammatory Response, run by Cardio Med Medical Center at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Systemic Inflammatory Response, Chronic Coronary Syndrome
- What is being tested?
- Cardiac imaging tests and Venous blood sample collection
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 5 Aug 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Cardio Med Medical Center
Târgu Mureş, 540124
Theodora Benedek, PhD, MD, +40-265-217-333, theodora.benedek@gmail.com
About this study
Official title: CCTA Study of Atheromatous Lesions, Coronary Hemodynamics and Systemic Inflammation in Patients With Vulnerable Plaques (COHESIVE STUDY)
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.
Read the detailed description
This is a clinical, observational cross sectional, mono-centric study which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed in collaboration with the University of Medicine, Pharmacy, Sciences and Technology "GE Palade".
The project will include 100 subjects with stable coronary artery disease (defined according to the ESC guidelines for management of patients with chronic coronary syndromes), presenting in out-patient conditions, who will undergo 128 slice CCTA evaluation of coronary artery tree anatomy, coronary plaque morphology, composition and degree of vulnerability.
Samples for systemic serum biomarkers for systemic inflammation will be collected at the moment of CCTA image acquisition for all patients. The endothelial coronary shear stress will be calculated with imaging post-processing techniques on the CT data acquired at baseline, by using computational fluid dynamics.
The study will be conducted over a period of 6 months, in which patients will be examined for clinical data, echocardiography assessment of left ventricular function, valvular disease, diastolic function, 12-lead ECG, cardiovascular risk assessment, systemic inflammation (based on serum levels of hsCRP, interleukin-6, MMP-9, periostin, adhesion molecules. Coronary plaque analysis will be conducted on an offline station by using dedicated post-processing software for detection of plaque morphology (length, volume, degree of stenosis, plaque location within the coronary tree, remodeling and eccentricity index), composition (lipid rich, fibrotic and calcified volumes), degree of vulnerability (identification of positive remodeling, low attenuation, spotty calcium, napkin ring sing). After plaque selection and analysis, computational fluid dynamics based on CCTA images will be performed on an offline dedicated station for coronary shear stress quantification.
Primary exclusion criteria include acute coronary syndromes at the moment of enrollment, with myocardial necrosis, the presence of coronary stents and extensive calcifications and suboptimal CCTA image acquisition that could interfere with plaque analysis, as well as contraindications for administration of contrast media agent (renal disease, allergies, thyroid dysfunction).
Study objectives:
Primary: to investigate the association between coronary plaque topography in different sites within the coronary tree (right versus left, proximal distal) and their vulnerability degree evaluated with CCTA.
Secondary: to assess the relationship between degree of plaque vulnerability, systemic inflammatory biomarkers and specific hemodynamic characteristics quantified by coronary shear stress computations in relation to plaque location.
Study procedures
- Clinical examination, medical history, cardiovascular risk assessment
- 12-lead ECG
- 2D transthoracic echocardiography with measurement of: cardiac diameters, volumes, valvular function and regurgitation, pressure gradients, pericardial fat thickness, pericardial effusion, left ventricular global and regional function and ejection fraction.
- 128-multislice CT coronary angiography with the evaluation of: epicardial fat volume, plaque burden, total and local calcium score, markers for lesion severity (degree of stenosis, lesion length, lumen area and diameter, minimum and maximum plaque thickness); morphological plaque characteristics (plaque related volumes, plaque burden, vascular indexes - remodeling and eccentricity index); plaque components evaluated via volumetric and planimetric units (necrotic core, fibrofatty tissue, fibrotic tissue, dense calcium); markers of plaque vulnerability (necrotic core, low attenuation plaque, spotty calcification, napkin ring sign, positive remodeling).
- Shear stress evaluation of CT acquired images and computational fluid dynamics
- Venous blood sample collection during the acute coronary event for evaluation of serum levels of hsCRP, IL-6, matrix metalloproteases - MMP9, Adhesion molecules (VCAM, ICAM, e-selectin, p-selectin), periostin.
- Data collection: In a dedicated database that includes all patient information, demographics, medical history, medication, therapeutic procedures, information derived from imaging techniques (echocardiography, CT angiography, CT imaging post-processing and shear stress evaluation).
- Conditions
- Coronary Artery Disease, Systemic Inflammatory Response, Chronic Coronary Syndrome, Atherosclerosis
- Being tested
- Cardiac imaging tests, Venous blood sample collection
- Keywords
- coronary vulnerable plaque, CCTA, Systemic inflammation, Coronary shear stress, Plaque topography
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac imaging testsDiagnostic 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 collectionDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Evaluation of association between serum levels of inflammatory biomarkers (hsCRP, IL-6, MMP-9, V-CAM, I-CAM, selectins, periostin) and markers of plaque characterization (morphology, composition degree of vulnerability) in relation to the coronary hemodynamic characteristics (by quantification of coronary shear stress based on CCTA images).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start5 Aug 2022
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardio Med Medical Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures, University Hospital of Targu Mures, Romania
- Responsible party
- Sponsor
- Investigators
- Diana Opincariu, MD, PhD, Study director, CardioMed Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488249
- Sponsor's protocol ID
- CM-75/2022-COHESIVE
- Acronym
- COHESIVE
- Status last verified
- Aug 2022
- First submitted
- 30 Jul 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available for interested parties.
Publications
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.
PubMed 32617720Opincariu 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.
PubMed 34362217Mester 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.
PubMed 35268316Opincariu 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
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.
PubMed 35240010Szilveszter 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.
PubMed 26280890
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCTA Study of Atheromatous Lesions, Coronary Hemodynamics and Systemic Inflammation in Patients With Vulnerable Plaques (COHESIVE STUDY)
- ClinicalTrials.gov ID
- NCT05488249
- Acronym / sponsor ID
- COHESIVE / CM-75/2022-COHESIVE
- Conditions
- Coronary Artery Disease, Systemic Inflammatory Response, Chronic Coronary Syndrome, Atherosclerosis
- Keywords
- coronary vulnerable plaque, CCTA, Systemic inflammation, Coronary shear stress, Plaque topography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cardio Med Medical CenterIndustry (pharma, biotech, devices)
- Collaborators
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures, University Hospital of Targu Mures, Romania
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a clinical, observational cross sectional, mono-centric study which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed in collaboration with the University of Medicine, Pharmacy, Sciences and Technology "GE Palade".
The project will include 100 subjects with stable coronary artery disease (defined according to the ESC guidelines for management of patients with chronic coronary syndromes), presenting in out-patient conditions, who will undergo 128 slice CCTA evaluation of coronary artery tree anatomy, coronary plaque morphology, composition and degree of vulnerability.
Samples for systemic serum biomarkers for systemic inflammation will be collected at the moment of CCTA image acquisition for all patients. The endothelial coronary shear stress will be calculated with imaging post-processing techniques on the CT data acquired at baseline, by using computational fluid dynamics.
The study will be conducted over a period of 6 months, in which patients will be examined for clinical data, echocardiography assessment of left ventricular function, valvular disease, diastolic function, 12-lead ECG, cardiovascular risk assessment, systemic inflammation (based on serum levels of hsCRP, interleukin-6, MMP-9, periostin, adhesion molecules. Coronary plaque analysis will be conducted on an offline station by using dedicated post-processing software for detection of plaque morphology (length, volume, degree of stenosis, plaque location within the coronary tree, remodeling and eccentricity index), composition (lipid rich, fibrotic and calcified volumes), degree of vulnerability (identification of positive remodeling, low attenuation, spotty calcium, napkin ring sing). After plaque selection and analysis, computational fluid dynamics based on CCTA images will be performed on an offline dedicated station for coronary shear stress quantification.
Primary exclusion criteria include acute coronary syndromes at the moment of enrollment, with myocardial necrosis, the presence of coronary stents and extensive calcifications and suboptimal CCTA image acquisition that could interfere with plaque analysis, as well as contraindications for administration of contrast media agent (renal disease, allergies, thyroid dysfunction).
Study objectives:
Primary: to investigate the association between coronary plaque topography in different sites within the coronary tree (right versus left, proximal distal) and their vulnerability degree evaluated with CCTA.
Secondary: to assess the relationship between degree of plaque vulnerability, systemic inflammatory biomarkers and specific hemodynamic characteristics quantified by coronary shear stress computations in relation to plaque location.
Study procedures
- Clinical examination, medical history, cardiovascular risk assessment
- 12-lead ECG
- 2D transthoracic echocardiography with measurement of: cardiac diameters, volumes, valvular function and regurgitation, pressure gradients, pericardial fat thickness, pericardial effusion, left ventricular global and regional function and ejection fraction.
- 128-multislice CT coronary angiography with the evaluation of: epicardial fat volume, plaque burden, total and local calcium score, markers for lesion severity (degree of stenosis, lesion length, lumen area and diameter, minimum and maximum plaque thickness); morphological plaque characteristics (plaque related volumes, plaque burden, vascular indexes - remodeling and eccentricity index); plaque components evaluated via volumetric and planimetric units (necrotic core, fibrofatty tissue, fibrotic tissue, dense calcium); markers of plaque vulnerability (necrotic core, low attenuation plaque, spotty calcification, napkin ring sign, positive remodeling).
- Shear stress evaluation of CT acquired images and computational fluid dynamics
- Venous blood sample collection during the acute coronary event for evaluation of serum levels of hsCRP, IL-6, matrix metalloproteases - MMP9, Adhesion molecules (VCAM, ICAM, e-selectin, p-selectin), periostin.
- Data collection: In a dedicated database that includes all patient information, demographics, medical history, medication, therapeutic procedures, information derived from imaging techniques (echocardiography, CT angiography, CT imaging post-processing and shear stress evaluation).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac imaging tests* 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. | Diagnostic test | – |
| Venous blood sample collectionVenous 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. | Diagnostic test | – |
Primary outcome
Relationship between coronary plaque localization on its degree of vulnerability
Time frame: through study completion, an average of 1 year
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)
1 secondary outcome
Relationship between systemic inflammation on coronary plaque vulnerability, according to plaque location and hemodynamic characteristics
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Background: PubMed 32617720Opincariu 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.
- Background: PubMed 34362217Opincariu 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.
- Background: PubMed 35268316Mester 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.
- BackgroundOpincariu 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: PubMed 35240010DISCHARGE 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.
- Background: PubMed 26280890Szilveszter 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available for interested parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Opincariu, MD, PhD study director
CardioMed Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Systemic Inflammatory Response, run by Cardio Med Medical Center at 1 site in Romania.
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 6 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: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Opincariu, MD, PhD (+40 265 217 333, diana.opincariu@yahoo.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between coronary plaque localization on its degree of vulnerability (time frame: through study completion, an average of 1 year). 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 NCT05488249, which also lists 6 linked publications.
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 16 May 2023.