Myocardial InfarctionNCT03308539
Prediction of Coronary Artery Disease Severity by Epicardial Adipose Tissue Thickness
An observational study of Myocardial Infarction, run by Osama Fekry at 1 site in Egypt.
Trial summary
is to test the hypotheses that epicardial adipose tissue can be a marker of severity of coronary artery disease in myocardial infarction patients Read more about this study
- Who is it for?
- Ages Up to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- echocardiography and cardiac magnetic resonance
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 1 Sep 2018
- 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 Up to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: acute myocardial infarction patiens not previously underwent percutaneous coronary angiography or coronary artery bypass grafting
Who may be able to join
- Normal thoracic shape
- Sinus rhythm
- without severe respiratory diseases
Who cannot join
- contraindication for cardiac magnetic resonance.
- Patients who previously underwent coronary artery bypass grafting or percutaneous coronary angiography prior to admission
- history of chronic kidney disease with glomerular filtration rate <30 mL/min
- pericardial and/or pleural effusion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Jacqueline George
Asyut, Single
hosam hassan, professor doctor, 01223971327, hosam_hasan@hotmail.com
heba el nagar, lecturer, 01001963100, Heba_M_elnagar@yahoo.com
About this study
Official title: Predictive Value of Epicardial Fat Thickness for Disease Severity in Coronary Artery Disease Patients
is to test the hypotheses that epicardial adipose tissue can be a marker of severity of coronary artery disease in myocardial infarction patients
Read the detailed description
epicardial adipose tissue is defined as the adipose tissue between the visceral pericardium and the outer margin of the myocardium which can be considered an endocrine organ that secretes pro-inflammatory and anti-inflammatory cytokines and chemokines including adiponectin.as investigators know, inflammatory response is an important factor in the coronary atherogenesis. Therefore,epicardial adipose tissue is likely to be connected with the severity of coronary artery disease.Recent studies showed that the thickness of the epicardial adipose tissue in patients with coronary artery disease was greater than that with normal coronary arteries.
epicardial adipose tissue will be assessed using transthoracic echocardiography and cardiac magnetic resonance which allows for an accurate volumetric quantification of epicardial fat.
- Conditions
- Myocardial Infarction
- Being tested
- echocardiography and cardiac magnetic resonance
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography and cardiac magnetic resonanceRadiation
transthoracic echocardiography and magnetic resonance imaging of the heart
| Study group | Role | What they receive |
|---|---|---|
| myocardial infarction patients | transthoracic echocardiography and cardiac magnetic resonance Receives: Radiation: echocardiography and cardiac magnetic resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of epicardial adipose tissue as marker of severity of coronary artery disease in myocardial infarction patients.
epicardial adipose tissue measurement using transthoracic echocardiography and cardiac magnetic resonance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osama Fekry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osama Fekry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308539
- Sponsor's protocol ID
- epicardial adipose tissue
- Status last verified
- Oct 2017
- First submitted
- 6 Oct 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Desferrioxamine and transfusional iron overload. Lancet. 1978 Mar 4;1(8062):479-80. No abstract available.
PubMed 76025
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Epicardial Fat Thickness for Disease Severity in Coronary Artery Disease Patients
- ClinicalTrials.gov ID
- NCT03308539
- Acronym / sponsor ID
- epicardial adipose tissue
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Osama FekryUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 12 Oct 2017 (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.
is to test the hypotheses that epicardial adipose tissue can be a marker of severity of coronary artery disease in myocardial infarction patients
Detailed description
epicardial adipose tissue is defined as the adipose tissue between the visceral pericardium and the outer margin of the myocardium which can be considered an endocrine organ that secretes pro-inflammatory and anti-inflammatory cytokines and chemokines including adiponectin.as investigators know, inflammatory response is an important factor in the coronary atherogenesis. Therefore,epicardial adipose tissue is likely to be connected with the severity of coronary artery disease.Recent studies showed that the thickness of the epicardial adipose tissue in patients with coronary artery disease was greater than that with normal coronary arteries.
epicardial adipose tissue will be assessed using transthoracic echocardiography and cardiac magnetic resonance which allows for an accurate volumetric quantification of epicardial fat.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myocardial infarction patients | – | Radiation: echocardiography and cardiac magnetic resonancetransthoracic echocardiography and cardiac magnetic resonance |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- acute myocardial infarction patiens not previously underwent percutaneous coronary angiography or coronary artery bypass grafting
Key inclusion criteria (3 listed)
- Normal thoracic shape
- Sinus rhythm
- without severe respiratory diseases
Key exclusion criteria (4 listed)
- contraindication for cardiac magnetic resonance.
- Patients who previously underwent coronary artery bypass grafting or percutaneous coronary angiography prior to admission
- history of chronic kidney disease with glomerular filtration rate <30 mL/min
- pericardial and/or pleural effusion.
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 |
|---|---|---|
| echocardiography and cardiac magnetic resonancetransthoracic echocardiography and magnetic resonance imaging of the heart | Radiation | myocardial infarction patients |
Primary outcome
measurement of epicardial adipose tissue as marker of severity of coronary artery disease in myocardial infarction patients.
Time frame: one year
epicardial adipose tissue measurement using transthoracic echocardiography and cardiac magnetic resonance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Results publication: PubMed 76025Desferrioxamine and transfusional iron overload. Lancet. 1978 Mar 4;1(8062):479-80. No abstract available.
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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.
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 Myocardial Infarction, run by Osama Fekry at 1 site in Egypt.
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 3 inclusion and 4 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 12 Oct 2017. 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 Egypt. 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 jacqueline george, master (01275502685 ext. assiut, jacquelinegeorge@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of epicardial adipose tissue as marker of severity of coronary artery disease in myocardial infarction patients. (time frame: one 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 NCT03308539, which also lists 1 linked publication.
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 12 Oct 2017.