Stable AnginaDATASETNCT04424121
CCTA, CACS and ECG Stress Testing in Patients With Suspected CAD: Precision Phenotyping and Financial Evaluation
A study testing CCTA in people with Stable Angina and Coronary Artery Disease, run by Aristotle University Of Thessaloniki at 3 sites in Greece.
Trial summary
The "DATASET-PRECISE", a 3-arm parallel randomized study, aims to provide new insights in risk stratification of patients with suspected CAD in the Greek population. The convergence of information derived from exercise ECG stress test, CACS, CCTA and metabolomic profiling in artificial intelligence algorithms… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Coronary Artery Disease, Atherosclerosis
- What is being tested?
- CCTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesGreece
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable symptoms and low to intermediate probability of coronary artery disease (CAD) referred for evaluation
- Patients without known history of CAD
- Patients older than 18 years
- Patients giving voluntary written consent to participate in the study
- Subject is willing to comply with study follow-up requirements
Who cannot join
- Patients with a previous history of CAD
- Patients who refuse to give written consent for participation in the study
- In the investigator's opinion, subject will not be able to comply with the follow-up requirements
- Known pregnancy
- Subject has a known allergy to contrast agent that cannot be adequately pre-medicated
- Inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner
- Severe renal failure (estimated Glomerular Filtration Rate-eGFR <30 mL/min)
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
Lefkos Stavros The Athens Clinic
Athens
Georgios Benetos, MD, PhD
National and Kapodistrian University of Athens, School of Medicine
Athens
Georgios Benetos, MD, PhD
Konstantina Aggeli, Prof. in Cardiology
Aristotle University of Thessaloniki, School of Medicine
Thessaloniki
Georgios Rampidis, MD, MSc
Haralambos Karvounis, MD, PhD
About this study
Official title: Cardiac CT, Calcium Scoring and ECG Stress Testing in Patients With Suspected Coronary Artery Disease: Precision Phenotyping and Financial Evaluation (The DATASET-PRECISE Randomized Trial)
The "DATASET-PRECISE", a 3-arm parallel randomized study, aims to provide new insights in risk stratification of patients with suspected CAD in the Greek population. The convergence of information derived from exercise ECG stress test, CACS, CCTA and metabolomic profiling in artificial intelligence algorithms describes in brief the main objective of this protocol. The design of the present proposal is based on current state-of-the-art literature, incorporating, however, additional innovative elements. It is about the first randomized study to be conducted in Greece, investigating the role of CCTA and CACS in CAD diagnosis and risk assessment. Moreover, the present protocol aims to integrate information on patients' metabolomic profiling. The process of the whole information by using artificial intelligence technology will lead to the development of new risk stratification algorithms, promoting further personalized diagnostic and therapeutic approach. Regarding Greece, this is the first prospectively enrolling medical database of this scale.
Read the detailed description
Symptom-based pre-test probability (PTP) scores that estimate the likelihood of obstructive CAD in stable chest pain have moderate accuracy. Appreciating and integrating the myriad risk predictors in an individual patient is a challenge for the clinician. To date, efforts to improve risk-stratification by using CCTA have largely relied upon luminal stenosis severity. The emphasis placed on this variable over others is in alignment with prior studies using invasive coronary angiography but ignores an array of other parameters important in the CAD pathogenic process, including coronary artery geometry, coronary calcium content, plaque composition, and plaque burden. As an increasing number of CCTA variables along with all clinical and metabolomic variables affecting risk need to be considered, the complexity of assessment increases, making it more difficult for a clinician to draw an overall conclusion regarding risk in an individual patient. Furthermore, the potential influence of unexpected interactions between several weaker predictors in an individual patient is often overlooked. In this study, we are seeking to develop an Artificial Intelligence (AI)-based model, utilizing clinical and metabolomic risk factors, serum biomarkers, CCTA imaging biomarkers, coronary artery calcium score and ECG stress testing variables, to predict the presence and the complexity of CAD. Moreover, we are trying to introduce an easy to use, cost-effective, clinical decision supporting tool. In clinical practice, the utilization of such an approach could improve risk stratification and help guide downstream personalized management. Briefly, the research objectives of the study are: 1. predict the risk of obstructive coronary artery disease, 2. quantify the burden and complexity of coronary atherosclerosis, 3. evaluate the prognostic risk in individual patients with suspected CAD, 4. provide more accurate diagnosis and risk stratification, 5. provide an easy to use, cost-effective clinical decision support tool, 6. improve decisions in low to intermediate risk patients regarding the need for further testing such as cardiac SPECT and invasive coronary angiography, as well as for the need for preventive therapies and finally, compare three diagnostic strategies in patients with suspected CAD in terms of efficacy and cost-effectiveness.
The "DATASET-PRECISE" is a prospective, multi-center, open-label, 3-arm parallel randomized study. Following clinical consultation, participants will be approached and randomized 1:1:1 to receive standard care plus ECG-stress testing or standard care plus ECG-stress testing and CACS or standard care plus ≥ 64-multidetector CCTA and CACS (Collaborating Organizations: 1st Cardiology Department of AUTH, 1st Cardiology Department of NKUA, Lefkos Stavros-The Athens Clinic \& Affidea Kozani Cardiac Imaging Center). Randomization will be conducted using a web-based system to ensure allocation concealment. The trial will enroll consecutive patients with stable symptoms and suspected CAD admitted to study clinical sites over a period of 12 months. Patients with a previous history of CAD and/or prior revascularization will be excluded. Subjects will undergo screening during the first day of examination, a 5ml blood sample will be collected one minute prior examination for metabolomic analysis (collaboration with the Lab. of Bioanalysis \& Toxicology, School of Medicine, AUTH) and will be followed for 18 months afterwards. The overall recruitment period is expected to last 12 months. The estimated total duration of the study from first patient screened to last patient last visit is 30 months.
Based on previous studies for 80% power at a two-sided P value of 0.05, we will need to recruit about 250 patients per group to detect a relative reduction in the combined MACE rate (cardiac death, non-fatal myocardial infarction, revascularization or chest-pain rehospitalization) of 10% in the CCTA arm. A sample size of N = 900 patients is a pragmatic approach for such a first clinical study in the Greek population. Health service costs will be assigned to the type and intensity of resource use, measured by the number of diagnostic and therapeutic procedures or interventions, medications, hospital clinic attendances and hospitalization episodes from randomization to 18 months of follow-up. Costs will be attributed to the need for: 1. additional invasive or noninvasive imaging, 2. drug therapy, 3. coronary revascularization and 4. hospitalization for chest pain.
- Being tested
- CCTA
- Keywords
- Coronary Computed Tomography Angiography, Coronary Artery Calcium Score, ECG Stress Test, Metabolomics, Precision Medicine, Artificial Intelligence, Machine Learning, Cost-Effectiveness Analysis, Clinical Decision Support Tool
- Medical subject headings
- Angina, Stable, Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTADiagnostic test
Coronary Computed Tomography Angiography
| Study group | Role | What they receive |
|---|---|---|
| Standard of care plus ECG Stress Testing | No intervention | Participants will be approached and randomized to receive standard care plus ECG-stress testing |
| Standard of care plus ECG Stress Testing and CACS | No intervention | Participants will be approached and randomized to receive standard care plus ECG-stress testing and coronary artery calcium scoring |
| Standard of care plus CCTA | Active comparator | Participants will be approached and randomized to receive standard care plus ≥ 64 multidetector coronary computed tomography angiography Receives: Diagnostic Test: CCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE)
Defined as cardiac death, non-fatal myocardial infarction or revascularization with percutaneous coronary intervention or coronary artery bypass graft surgery. Revascularization procedures within 6 weeks after the index CCTA will be excluded because they may be triggered by the CCTA findings per se
Measured: 18 months
Chest-pain rehospitalization
Frequency (%) of chest-pain rehospitalization
Measured: 18 months
Secondary outcomes (4)
Frequency of angina [Seattle Angina Questionnaire (SAQ)]
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Scores range from 0 to 100, where higher scores indicate better function (less physical limitation, less angina and better quality of life)
Measured: 6 months
Frequency of angina [Seattle Angina Questionnaire (SAQ)]
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Scores range from 0 to 100, where higher scores indicate better function (less physical limitation, less angina and better quality of life)
Measured: 12 months
Frequency of angina [Seattle Angina Questionnaire (SAQ)]
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Scores range from 0 to 100, where higher scores indicate better function (less physical limitation, less angina and better quality of life)
Measured: 18 months
Generic health status [Medical Outcomes Study 12-Item Short Form (SF-12)]
The Medical Outcomes Study 12-Item Short Form (SF-12) is a general health questionnaire and is computed using the scores of 12 questions ranging from 0 to 100, where 0 indicates the lowest level of health and 100 indicates the highest level of health
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jan 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, 3-arm parallel randomized study
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Lefkos Stavros The Athens Clinic, National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Georgios P Rampidis, MD, MSc, Aristotle University Of Thessaloniki
- Investigators
- Haralambos Karvounis, Prof. in Cardiology, Study chair, Aristotle University Of ThessalonikiGeorgios Giannakoulas, Prof. in Cardiology, Study director, Aristotle University Of ThessalonikiPeriklis Kounatiadis, MD, PhD, Principal investigator, Aristotle University Of ThessalonikiPanagiotis Bamidis, Prof. in Bioinformatics, Principal investigator, Aristotle University Of ThessalonikiGeorgios Rampidis, MD, MSc, Principal investigator, Aristotle University Of ThessalonikiOlga Deda, PhD, Principal investigator, Aristotle University Of ThessalonikiAntonios Billis, PhD, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424121
- Sponsor's protocol ID
- DATASET PRECISE_01062020_03448
- Acronym
- DATASET
- Status last verified
- Sep 2020
- First submitted
- 6 Jun 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benz DC, Benetos G, Rampidis G, von Felten E, Bakula A, Sustar A, Kudura K, Messerli M, Fuchs TA, Gebhard C, Pazhenkottil AP, Kaufmann PA, Buechel RR. Validation of deep-learning image reconstruction for coronary computed tomography angiography: Impact on noise, image quality and diagnostic accuracy. J Cardiovasc Comput Tomogr. 2020 Sep-Oct;14(5):444-451. doi: 10.1016/j.jcct.2020.01.002. Epub 2020 Jan 13.
PubMed 31974008Benetos G, Buechel RR, Goncalves M, Benz DC, von Felten E, Rampidis GP, Clerc OF, Messerli M, Giannopoulos AA, Gebhard C, Fuchs TA, Pazhenkottil AP, Kaufmann PA, Grani C. Coronary artery volume index: a novel CCTA-derived predictor for cardiovascular events. Int J Cardiovasc Imaging. 2020 Apr;36(4):713-722. doi: 10.1007/s10554-019-01750-2. Epub 2020 Jan 1.
PubMed 31894527Rampidis GP, Benetos G, Benz DC, Giannopoulos AA, Buechel RR. A guide for Gensini Score calculation. Atherosclerosis. 2019 Aug;287:181-183. doi: 10.1016/j.atherosclerosis.2019.05.012. Epub 2019 May 10. No abstract available.
PubMed 31104809Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
PubMed 31504439Budoff MJ, Mayrhofer T, Ferencik M, Bittner D, Lee KL, Lu MT, Coles A, Jang J, Krishnam M, Douglas PS, Hoffmann U; PROMISE Investigators. Prognostic Value of Coronary Artery Calcium in the PROMISE Study (Prospective Multicenter Imaging Study for Evaluation of Chest Pain). Circulation. 2017 Nov 21;136(21):1993-2005. doi: 10.1161/CIRCULATIONAHA.117.030578. Epub 2017 Aug 28.
PubMed 28847895SCOT-HEART Investigators; Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.
PubMed 30145934Hilvo M, Meikle PJ, Pedersen ER, Tell GS, Dhar I, Brenner H, Schottker B, Laaperi M, Kauhanen D, Koistinen KM, Jylha A, Huynh K, Mellett NA, Tonkin AM, Sullivan DR, Simes J, Nestel P, Koenig W, Rothenbacher D, Nygard O, Laaksonen R. Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients. Eur Heart J. 2020 Jan 14;41(3):371-380. doi: 10.1093/eurheartj/ehz387.
PubMed 31209498von Felten E, Messerli M, Giannopoulos AA, Benz DC, Schwyzer M, Benetos G, Rampidis G, Patriki D, Kamani CH, Grani C, Fuchs TA, Pazhenkottil AP, Gebhard C, Kaufmann PA, Buechel RR. Potential of Radiation Dose Reduction by Optimizing Z-Axis Coverage in Coronary Computed Tomography Angiography on a Latest-Generation 256-Slice Scanner. J Comput Assist Tomogr. 2020 Mar/Apr;44(2):289-294. doi: 10.1097/RCT.0000000000000993.
PubMed 32195809
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac CT, Calcium Scoring and ECG Stress Testing in Patients With Suspected Coronary Artery Disease: Precision Phenotyping and Financial Evaluation (The DATASET-PRECISE Randomized Trial)
- ClinicalTrials.gov ID
- NCT04424121
- Acronym / sponsor ID
- DATASET / DATASET PRECISE_01062020_03448
- Keywords
- Coronary Computed Tomography Angiography, Coronary Artery Calcium Score, ECG Stress Test, Metabolomics, Precision Medicine, Artificial Intelligence, Machine Learning, Cost-Effectiveness Analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Lefkos Stavros The Athens Clinic, National and Kapodistrian University of Athens
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jun 2020 (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.
The "DATASET-PRECISE", a 3-arm parallel randomized study, aims to provide new insights in risk stratification of patients with suspected CAD in the Greek population. The convergence of information derived from exercise ECG stress test, CACS, CCTA and metabolomic profiling in artificial intelligence algorithms describes in brief the main objective of this protocol. The design of the present proposal is based on current state-of-the-art literature, incorporating, however, additional innovative elements. It is about the first randomized study to be conducted in Greece, investigating the role of CCTA and CACS in CAD diagnosis and risk assessment. Moreover, the present protocol aims to integrate information on patients' metabolomic profiling. The process of the whole information by using artificial intelligence technology will lead to the development of new risk stratification algorithms, promoting further personalized diagnostic and therapeutic approach. Regarding Greece, this is the first prospectively enrolling medical database of this scale.
Detailed description
Symptom-based pre-test probability (PTP) scores that estimate the likelihood of obstructive CAD in stable chest pain have moderate accuracy. Appreciating and integrating the myriad risk predictors in an individual patient is a challenge for the clinician. To date, efforts to improve risk-stratification by using CCTA have largely relied upon luminal stenosis severity. The emphasis placed on this variable over others is in alignment with prior studies using invasive coronary angiography but ignores an array of other parameters important in the CAD pathogenic process, including coronary artery geometry, coronary calcium content, plaque composition, and plaque burden. As an increasing number of CCTA variables along with all clinical and metabolomic variables affecting risk need to be considered, the complexity of assessment increases, making it more difficult for a clinician to draw an overall conclusion regarding risk in an individual patient. Furthermore, the potential influence of unexpected interactions between several weaker predictors in an individual patient is often overlooked. In this study, we are seeking to develop an Artificial Intelligence (AI)-based model, utilizing clinical and metabolomic risk factors, serum biomarkers, CCTA imaging biomarkers, coronary artery calcium score and ECG stress testing variables, to predict the presence and the complexity of CAD. Moreover, we are trying to introduce an easy to use, cost-effective, clinical decision supporting tool. In clinical practice, the utilization of such an approach could improve risk stratification and help guide downstream personalized management. Briefly, the research objectives of the study are: 1. predict the risk of obstructive coronary artery disease, 2. quantify the burden and complexity of coronary atherosclerosis, 3. evaluate the prognostic risk in individual patients with suspected CAD, 4. provide more accurate diagnosis and risk stratification, 5. provide an easy to use, cost-effective clinical decision support tool, 6. improve decisions in low to intermediate risk patients regarding the need for further testing such as cardiac SPECT and invasive coronary angiography, as well as for the need for preventive therapies and finally, compare three diagnostic strategies in patients with suspected CAD in terms of efficacy and cost-effectiveness.
The "DATASET-PRECISE" is a prospective, multi-center, open-label, 3-arm parallel randomized study. Following clinical consultation, participants will be approached and randomized 1:1:1 to receive standard care plus ECG-stress testing or standard care plus ECG-stress testing and CACS or standard care plus ≥ 64-multidetector CCTA and CACS (Collaborating Organizations: 1st Cardiology Department of AUTH, 1st Cardiology Department of NKUA, Lefkos Stavros-The Athens Clinic \& Affidea Kozani Cardiac Imaging Center). Randomization will be conducted using a web-based system to ensure allocation concealment. The trial will enroll consecutive patients with stable symptoms and suspected CAD admitted to study clinical sites over a period of 12 months. Patients with a previous history of CAD and/or prior revascularization will be excluded. Subjects will undergo screening during the first day of examination, a 5ml blood sample will be collected one minute prior examination for metabolomic analysis (collaboration with the Lab. of Bioanalysis \& Toxicology, School of Medicine, AUTH) and will be followed for 18 months afterwards. The overall recruitment period is expected to last 12 months. The estimated total duration of the study from first patient screened to last patient last visit is 30 months.
Based on previous studies for 80% power at a two-sided P value of 0.05, we will need to recruit about 250 patients per group to detect a relative reduction in the combined MACE rate (cardiac death, non-fatal myocardial infarction, revascularization or chest-pain rehospitalization) of 10% in the CCTA arm. A sample size of N = 900 patients is a pragmatic approach for such a first clinical study in the Greek population. Health service costs will be assigned to the type and intensity of resource use, measured by the number of diagnostic and therapeutic procedures or interventions, medications, hospital clinic attendances and hospitalization episodes from randomization to 18 months of follow-up. Costs will be attributed to the need for: 1. additional invasive or noninvasive imaging, 2. drug therapy, 3. coronary revascularization and 4. hospitalization for chest pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label, 3-arm parallel randomized study
| Arm | Type | Receives |
|---|---|---|
| Standard of care plus ECG Stress Testing | No intervention | –Participants will be approached and randomized to receive standard care plus ECG-stress testing |
| Standard of care plus ECG Stress Testing and CACS | No intervention | –Participants will be approached and randomized to receive standard care plus ECG-stress testing and coronary artery calcium scoring |
| Standard of care plus CCTA | Active comparator | Diagnostic Test: CCTAParticipants will be approached and randomized to receive standard care plus ≥ 64 multidetector coronary computed tomography angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with stable symptoms and low to intermediate probability of coronary artery disease (CAD) referred for evaluation
- Patients without known history of CAD
- Patients older than 18 years
- Patients giving voluntary written consent to participate in the study
- Subject is willing to comply with study follow-up requirements
Key exclusion criteria (7 listed)
- Patients with a previous history of CAD
- Patients who refuse to give written consent for participation in the study
- In the investigator's opinion, subject will not be able to comply with the follow-up requirements
- Known pregnancy
- Subject has a known allergy to contrast agent that cannot be adequately pre-medicated
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 |
|---|---|---|
| CCTACoronary Computed Tomography Angiography | Diagnostic test | Standard of care plus CCTA |
Primary outcome
Major Adverse Cardiac Events (MACE)
Time frame: 18 months
Defined as cardiac death, non-fatal myocardial infarction or revascularization with percutaneous coronary intervention or coronary artery bypass graft surgery. Revascularization procedures within 6 weeks after the index CCTA will be excluded because they may be triggered by the CCTA findings per se
Chest-pain rehospitalization
Time frame: 18 months
Frequency (%) of chest-pain rehospitalization
4 secondary outcomes
Frequency of angina [Seattle Angina Questionnaire (SAQ)]
Time frame: 6 months
Frequency of angina [Seattle Angina Questionnaire (SAQ)]
Time frame: 12 months
Frequency of angina [Seattle Angina Questionnaire (SAQ)]
Time frame: 18 months
Generic health status [Medical Outcomes Study 12-Item Short Form (SF-12)]
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Background: PubMed 31974008Benz DC, Benetos G, Rampidis G, von Felten E, Bakula A, Sustar A, Kudura K, Messerli M, Fuchs TA, Gebhard C, Pazhenkottil AP, Kaufmann PA, Buechel RR. Validation of deep-learning image reconstruction for coronary computed tomography angiography: Impact on noise, image quality and diagnostic accuracy. J Cardiovasc Comput Tomogr. 2020 Sep-Oct;14(5):444-451. doi: 10.1016/j.jcct.2020.01.002. Epub 2020 Jan 13.
- Background: PubMed 31894527Benetos G, Buechel RR, Goncalves M, Benz DC, von Felten E, Rampidis GP, Clerc OF, Messerli M, Giannopoulos AA, Gebhard C, Fuchs TA, Pazhenkottil AP, Kaufmann PA, Grani C. Coronary artery volume index: a novel CCTA-derived predictor for cardiovascular events. Int J Cardiovasc Imaging. 2020 Apr;36(4):713-722. doi: 10.1007/s10554-019-01750-2. Epub 2020 Jan 1.
- Background: PubMed 31104809Rampidis GP, Benetos G, Benz DC, Giannopoulos AA, Buechel RR. A guide for Gensini Score calculation. Atherosclerosis. 2019 Aug;287:181-183. doi: 10.1016/j.atherosclerosis.2019.05.012. Epub 2019 May 10. No abstract available.
- Background: PubMed 31504439Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
- Background: PubMed 28847895Budoff MJ, Mayrhofer T, Ferencik M, Bittner D, Lee KL, Lu MT, Coles A, Jang J, Krishnam M, Douglas PS, Hoffmann U; PROMISE Investigators. Prognostic Value of Coronary Artery Calcium in the PROMISE Study (Prospective Multicenter Imaging Study for Evaluation of Chest Pain). Circulation. 2017 Nov 21;136(21):1993-2005. doi: 10.1161/CIRCULATIONAHA.117.030578. Epub 2017 Aug 28.
- Background: PubMed 30145934SCOT-HEART Investigators; Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.
- Background: PubMed 31209498Hilvo M, Meikle PJ, Pedersen ER, Tell GS, Dhar I, Brenner H, Schottker B, Laaperi M, Kauhanen D, Koistinen KM, Jylha A, Huynh K, Mellett NA, Tonkin AM, Sullivan DR, Simes J, Nestel P, Koenig W, Rothenbacher D, Nygard O, Laaksonen R. Development and validation of a ceramide- and phospholipid-based cardiovascular risk estimation score for coronary artery disease patients. Eur Heart J. 2020 Jan 14;41(3):371-380. doi: 10.1093/eurheartj/ehz387.
- Background: PubMed 32195809von Felten E, Messerli M, Giannopoulos AA, Benz DC, Schwyzer M, Benetos G, Rampidis G, Patriki D, Kamani CH, Grani C, Fuchs TA, Pazhenkottil AP, Gebhard C, Kaufmann PA, Buechel RR. Potential of Radiation Dose Reduction by Optimizing Z-Axis Coverage in Coronary Computed Tomography Angiography on a Latest-Generation 256-Slice Scanner. J Comput Assist Tomogr. 2020 Mar/Apr;44(2):289-294. doi: 10.1097/RCT.0000000000000993.
- Individual participant dataSharing planned: No
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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.
Haralambos Karvounis, Prof. in Cardiology study chair
Aristotle University Of Thessaloniki
Georgios Giannakoulas, Prof. in Cardiology study director
Aristotle University Of Thessaloniki
Periklis Kounatiadis, MD, PhD principal investigator
Aristotle University Of Thessaloniki
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCTA in people with Stable Angina and Coronary Artery Disease, run by Aristotle University Of Thessaloniki at 3 sites in Greece.
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 5 inclusion and 7 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 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. 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 Georgios Rampidis, MD, MSc (2310994830 ext. +30, grampidi@auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) (time frame: 18 months). The study lists 2 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 NCT04424121, which also lists 8 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 14 Sep 2020.