CT - Coronary ThrombosisNCT06552663
The Diagnostic Power Of Coronary CT Angiography In Patients With Chest Pain And Zero Calcium Score
An observational study of CT - Coronary Thrombosis, run by Assiut University.
Trial summary
To prove the non-used wide diagnostic range of CCTA in diagnosis of other causes of chest pain in addition to the traditional known role in coronary atherosclerosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CT - Coronary Thrombosis
- What is being tested?
- CCTA
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Dec 2025
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * community sample * primary care clinic
Who may be able to join
- patients with chest pain whom are referred by cardiologist for coronary CT angiography and coronary artery calcium score to detect atherosclerosis .
Who cannot join
- Patients who refuse to sign the consent
- Subjects suspected of having myocardial infarction, unstable angina pectoris, or coronary artery disease
- Subjects who experienced heart attack within 40 days prior to the CT scan
- Subjects with a diagnosed complicated heart anomaly
- BMI > 35 kg/m2
- Serum creatinine ≥ 1.5 mg/dl
Show all 10Show fewer
- Pregnant subjects
- Subjects with a history of hypersensitivity reaction to contrast agents
- Subjects with contraindications to the use of nitroglycerine
- Subjects who plan to participate or enroll in other randomized clinical trials for cardiovascular disease.
Trial locations and contacts
No sites are listed yet.
hamdy M ibrahim, Professor contact
About this study
Official title: The Diagnostic Power Of Coronary Ct Angiography In Patients With Chest Pain And Zero Calcium Score
To prove the non-used wide diagnostic range of CCTA in diagnosis of other causes of chest pain in addition to the traditional known role in coronary atherosclerosis.
Read the detailed description
The heart is a specialized muscular organ which receives blood via major veins) SVC, IVC ,CS( then pumps it through the arteries (Aorta and Pulmonary artery) towards the systemic and pulmonary circulations. Non oxygenated blood enters the heart via SVC, IVC and CS, passes to the lungs to be oxygenated via the Pulmonary artery then returns to the heart via the Pulmonary veins and finally to the systemic circulation through Aorta.
Cardiac muscles are unique and differs from skeletal and smooth muscles to suit their function, and they are not liable to regenerate like all cells in the body, the cardiac muscles needs to be supplied with oxygen, nutrients and their metabolic wastes must be drained away. This is achieved by the coronary circulation which formed of two main arteries that arise just above the aortic valve, These are the right and left main coronary arteries and their branches. the venous drainage is through the major cardiac veins towards CS that finally drains at the right atrium. [1] As a result any affection of coronary arteries or interruption of blood flow inside it will cause weakness or death of cardiac cells (myocardium).The diseases affecting coronary arteries may be congenital e.g. abnormal course of the coronary arteries or myocardial bridge , traumatic e.g. dissection, inflammatory e.g. Takayasu's arteritis (TAK) , vascular e.g. aneurysm, lastly and the most common is atherosclerosis. [2] Atherosclerosis causes variable degrees of occlusion of the coronary arteries and results in a demand-supply mismatch of oxygen. it typically involves the formation of plaques in the arterial lumen of that impedes blood flow, atherosclerosis may be diffuse (mild subintimal affection), focal or multifocal called atherosclerotic plaques. Plaque is a build-up of fatty material that narrows the vessel lumen and impedes the blood flow, (fatty streak) Which is formed by subendothelial deposition of lipid-laden macrophages (foam cells), smooth muscles and collagen. Over time, this plaque could grow in size or become stable if no further insult occurs to the endothelium. If it becomes stable, a fibrous cap will form, and the lesion will become calcified over time. The drawback of calcified plaque is stenosis that impedes the blood supply while that of soft plaque is liability to further growth, detachment causing arterial occlusion or external rupture causing hemopericardium. [3] So that it is an advantage of CT over coronary catheterization extra coronary lesions either vascular e.g. aortic dissection, pulmonary embolism, cardiac e.g. pericarditis, extracardiac and mediastinal e.g. GERD, or even pleurisy, myositis and other chest pathologies via large FOV scanning through another phase. Cardiovascular diseases do not frequently have symptoms but may cause chest pain which is the most important symptom in CVDs, and may be a sign of other diseases like vascular, inflammatory …etc.
In the past CADs diagnosis could be done by many tests like ECG, blood tests, Cardiac catheterization and angiogram Which is invasive despite of high real time value and ability to place a stent or balloon dilatation. [4] Recently multidetector computed tomography (CT) and CT angiography could be done due to recent equipment that could match the cardiac motion and avoid the artifacts .
A CT scan of the heart can show calcium deposits and blockages in the coronary arteries and be calculated by calcium score, The calcium score is calculated based on the amount of calcification in the vessel walls of coronary arteries observed in a cardiac (CT) scan, Many methods have been used in calcium scoring e.g. Agatston calcium score which is the most popular one. A higher score indicates a larger amount of calcium deposition. However; Ca score of zero is not a sign of negative CVDs, so that CCTA become a must and don't just depend on the coronary Ca score alone.
A CT coronary angiogram is mainly used to check for narrowed or blocked coronary artery by any plaque even the soft non calcified ones . However, it can check for other heart conditions such congenital heart disease, valvular heart disease, carditis, aortic aneurysms…etc.
A CT coronary angiogram differs from a standard coronary angiogram. Which is an invasive technique that could only see the lumen of the artery not the wall itself and calcium score is not available, yet still a real time technique and have a therapeutic value at the same time. [5]
- Conditions
- CT - Coronary Thrombosis
- Being tested
- CCTA
- Medical subject headings
- Coronary Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTADevice
Coronary CT angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score . Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score . Evaluate outcome of coronary CT angiography
Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CT - Coronary ThrombosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdellah Farrag Abdelrheim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552663
- Sponsor's protocol ID
- Coronary CT Angiography
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buckberg GD, Nanda NC, Nguyen C, Kocica MJ. What Is the Heart? Anatomy, Function, Pathophysiology, and Misconceptions. J Cardiovasc Dev Dis. 2018 Jun 4;5(2):33. doi: 10.3390/jcdd5020033.
PubMed 29867011Villa AD, Sammut E, Nair A, Rajani R, Bonamini R, Chiribiri A. Coronary artery anomalies overview: The normal and the abnormal. World J Radiol. 2016 Jun 28;8(6):537-55. doi: 10.4329/wjr.v8.i6.537.
PubMed 27358682Lusis AJ. Atherosclerosis. Nature. 2000 Sep 14;407(6801):233-41. doi: 10.1038/35025203.
PubMed 11001066Nelson AJ, Ardissino M, Psaltis PJ. Current approach to the diagnosis of atherosclerotic coronary artery disease: more questions than answers. Ther Adv Chronic Dis. 2019 Nov 1;10:2040622319884819. doi: 10.1177/2040622319884819. eCollection 2019.
PubMed 31700595Doris M, Newby DE. Coronary CT Angiography as a Diagnostic and Prognostic Tool: Perspectives from the SCOT-HEART Trial. Curr Cardiol Rep. 2016 Feb;18(2):18. doi: 10.1007/s11886-015-0695-4.
PubMed 26782999
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Power Of Coronary Ct Angiography In Patients With Chest Pain And Zero Calcium Score
- ClinicalTrials.gov ID
- NCT06552663
- Acronym / sponsor ID
- Coronary CT Angiography
- Conditions
- CT - Coronary Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Aug 2024 (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.
To prove the non-used wide diagnostic range of CCTA in diagnosis of other causes of chest pain in addition to the traditional known role in coronary atherosclerosis.
Detailed description
The heart is a specialized muscular organ which receives blood via major veins) SVC, IVC ,CS( then pumps it through the arteries (Aorta and Pulmonary artery) towards the systemic and pulmonary circulations. Non oxygenated blood enters the heart via SVC, IVC and CS, passes to the lungs to be oxygenated via the Pulmonary artery then returns to the heart via the Pulmonary veins and finally to the systemic circulation through Aorta.
Cardiac muscles are unique and differs from skeletal and smooth muscles to suit their function, and they are not liable to regenerate like all cells in the body, the cardiac muscles needs to be supplied with oxygen, nutrients and their metabolic wastes must be drained away. This is achieved by the coronary circulation which formed of two main arteries that arise just above the aortic valve, These are the right and left main coronary arteries and their branches. the venous drainage is through the major cardiac veins towards CS that finally drains at the right atrium. [1] As a result any affection of coronary arteries or interruption of blood flow inside it will cause weakness or death of cardiac cells (myocardium).The diseases affecting coronary arteries may be congenital e.g. abnormal course of the coronary arteries or myocardial bridge , traumatic e.g. dissection, inflammatory e.g. Takayasu's arteritis (TAK) , vascular e.g. aneurysm, lastly and the most common is atherosclerosis. [2] Atherosclerosis causes variable degrees of occlusion of the coronary arteries and results in a demand-supply mismatch of oxygen. it typically involves the formation of plaques in the arterial lumen of that impedes blood flow, atherosclerosis may be diffuse (mild subintimal affection), focal or multifocal called atherosclerotic plaques. Plaque is a build-up of fatty material that narrows the vessel lumen and impedes the blood flow, (fatty streak) Which is formed by subendothelial deposition of lipid-laden macrophages (foam cells), smooth muscles and collagen. Over time, this plaque could grow in size or become stable if no further insult occurs to the endothelium. If it becomes stable, a fibrous cap will form, and the lesion will become calcified over time. The drawback of calcified plaque is stenosis that impedes the blood supply while that of soft plaque is liability to further growth, detachment causing arterial occlusion or external rupture causing hemopericardium. [3] So that it is an advantage of CT over coronary catheterization extra coronary lesions either vascular e.g. aortic dissection, pulmonary embolism, cardiac e.g. pericarditis, extracardiac and mediastinal e.g. GERD, or even pleurisy, myositis and other chest pathologies via large FOV scanning through another phase. Cardiovascular diseases do not frequently have symptoms but may cause chest pain which is the most important symptom in CVDs, and may be a sign of other diseases like vascular, inflammatory …etc.
In the past CADs diagnosis could be done by many tests like ECG, blood tests, Cardiac catheterization and angiogram Which is invasive despite of high real time value and ability to place a stent or balloon dilatation. [4] Recently multidetector computed tomography (CT) and CT angiography could be done due to recent equipment that could match the cardiac motion and avoid the artifacts .
A CT scan of the heart can show calcium deposits and blockages in the coronary arteries and be calculated by calcium score, The calcium score is calculated based on the amount of calcification in the vessel walls of coronary arteries observed in a cardiac (CT) scan, Many methods have been used in calcium scoring e.g. Agatston calcium score which is the most popular one. A higher score indicates a larger amount of calcium deposition. However; Ca score of zero is not a sign of negative CVDs, so that CCTA become a must and don't just depend on the coronary Ca score alone.
A CT coronary angiogram is mainly used to check for narrowed or blocked coronary artery by any plaque even the soft non calcified ones . However, it can check for other heart conditions such congenital heart disease, valvular heart disease, carditis, aortic aneurysms…etc.
A CT coronary angiogram differs from a standard coronary angiogram. Which is an invasive technique that could only see the lumen of the artery not the wall itself and calcium score is not available, yet still a real time technique and have a therapeutic value at the same time. [5]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * community sample * primary care clinic
Key inclusion criteria (1 listed)
- patients with chest pain whom are referred by cardiologist for coronary CT angiography and coronary artery calcium score to detect atherosclerosis .
Key exclusion criteria (10 listed)
- Patients who refuse to sign the consent
- Subjects suspected of having myocardial infarction, unstable angina pectoris, or coronary artery disease
- Subjects who experienced heart attack within 40 days prior to the CT scan
- Subjects with a diagnosed complicated heart anomaly
- BMI > 35 kg/m2
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 CT angiography | Device | – |
Primary outcome
Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score . Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score . Evaluate outcome of coronary CT angiography
Time frame: two years
Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Background: PubMed 29867011Buckberg GD, Nanda NC, Nguyen C, Kocica MJ. What Is the Heart? Anatomy, Function, Pathophysiology, and Misconceptions. J Cardiovasc Dev Dis. 2018 Jun 4;5(2):33. doi: 10.3390/jcdd5020033.
- Background: PubMed 27358682Villa AD, Sammut E, Nair A, Rajani R, Bonamini R, Chiribiri A. Coronary artery anomalies overview: The normal and the abnormal. World J Radiol. 2016 Jun 28;8(6):537-55. doi: 10.4329/wjr.v8.i6.537.
- Background: PubMed 11001066Lusis AJ. Atherosclerosis. Nature. 2000 Sep 14;407(6801):233-41. doi: 10.1038/35025203.
- Background: PubMed 31700595Nelson AJ, Ardissino M, Psaltis PJ. Current approach to the diagnosis of atherosclerotic coronary artery disease: more questions than answers. Ther Adv Chronic Dis. 2019 Nov 1;10:2040622319884819. doi: 10.1177/2040622319884819. eCollection 2019.
- Background: PubMed 26782999Doris M, Newby DE. Coronary CT Angiography as a Diagnostic and Prognostic Tool: Perspectives from the SCOT-HEART Trial. Curr Cardiol Rep. 2016 Feb;18(2):18. doi: 10.1007/s11886-015-0695-4.
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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.
hamdy M ibrahim, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of CT - Coronary Thrombosis, run by Assiut University.
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 1 inclusion and 10 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed A farrag, resident (01014849980, lithimohamed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score . Evaluate outcome of coronary CT angiography in cases with chest pain with zero calcium score . Evaluate outcome of coronary CT angiography (time frame: two years). 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 NCT06552663, which also lists 5 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 Aug 2024.