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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mohamed A farrag, resident contact

01014849980

lithimohamed@gmail.com

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]

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.

  1. 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.

  1. First posted14 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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
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 29867011
  • Villa 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 27358682
  • Lusis AJ. Atherosclerosis. Nature. 2000 Sep 14;407(6801):233-41. doi: 10.1038/35025203.

    PubMed 11001066
  • Nelson 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 31700595
  • Doris 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

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.

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