Coronary StenosisNCT02802046
Evaluation of the Correlation Between the Coronary Stenosis Degree With FFRCT and the Grade of Stable Angina Pectoris
An observational study of Coronary Stenosis and Angina Pectoris, run by Guiyang No.4 People's Hospital.
Trial summary
Angina pectoris is the most common clinical manifestation of coronary heart disease（CHD）, which is the main feature of chest pain caused by transient myocardial ischemia. Chronic stable angina pectoris is the degree, frequency, nature and cause of angina pectoris in patients with no significant change in a few weeks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Stenosis, Angina Pectoris
- What is being tested?
- Computed tomographic angiography of coronary artery
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: From 2015 to 2017 in our hospital for clinical diagnosis of coronary heart disease and computed tomographic angiography of coronary artery(CCTA) examination of patients.
Who may be able to join
- After computed tomographic angiography of coronary artery (CCTA) for the diagnosis of coronary heart disease patients
Who cannot join
- First, the patients with hematological diseases, infectious disease, end-stage renal disease and malignant tumor and other diseases. Second, the patients with acute myocardial infarction. Last, the percutaneous coronary intervention(PCI) and coronary artery bypass grafting (GABG) after the operation.
Trial locations and contacts
No sites are listed yet.
About this study
Angina pectoris is the most common clinical manifestation of coronary heart disease（CHD）, which is the main feature of chest pain caused by transient myocardial ischemia. Chronic stable angina pectoris is the degree, frequency, nature and cause of angina pectoris in patients with no significant change in a few weeks. The disease incidence is complex, difficult to diagnosis and treatment, clinical should be combined with various inspection methods for diagnosis and differential diagnosis. Fractional flow reserve of computerized tomographic scanning (FFRCT ) allows computerized tomographic scanning（CT） to scan the determination of coronary blood flow and blood pressure in the heart at rest and hyperemia, but no need to additional check or drugs. This technique has been used for noninvasive fractional flow reserve (FFR) in the calculation, assuming normal artery, calculated by the ratio of the maximum blood flow and blood flow of coronary artery stenosis of an artery. Along with the development and progress of computational fluid dynamics, in the resting state by computed tomographic angiography of coronary artery(CCTA) image data based, simulation of coronary artery maximal hyperemia and according to the 3-dimensional model of the traditional method of reconstruction of coronary arterial tree and ventricular muscle structure, and in order to calculated coronary blood flow and pressure. FFRCT is a novel non-invasive examination method, using computed tomographic angiography of coronary artery image data can be calculated FFR, and preliminary study proved that it has a high degree of correlation with traumatic FFR. Therefore, this study aims to evaluate the correlation between the degree of coronary stenosis and the grading of angina pectoris by noninvasive means --FFRCT, in order to provide a new idea for the diagnosis and differential diagnosis of coronary heart disease.
- Conditions
- Coronary Stenosis, Angina Pectoris
- Being tested
- Computed tomographic angiography of coronary artery
- Keywords
- FFRCT, Angina pectoris grade, Fractional flow reserve, CCTA
- Medical subject headings
- Coronary Stenosis, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographic angiography of coronary arteryRadiation
| Study group | Role | What they receive |
|---|---|---|
| FFR≦0.8 | FFR is a score of 0 to 1, FFR < 0.75, has proved almost always accompanied by myocardial ischemia. Receives: Radiation: Computed tomographic angiography of coronary artery | |
| FFR>0.8 | FFR > 0.80 almost never associated with myocardial ischemia. Receives: Radiation: Computed tomographic angiography of coronary artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFR Value
Measured: 1 years
Secondary outcomes (1)
CCS Class
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies 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
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guiyang No.4 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Song, Guiyang No.4 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802046
- Sponsor's protocol ID
- 42925078-2
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Taylor CA, Fonte TA, Min JK. Computational fluid dynamics applied to cardiac computed tomography for noninvasive quantification of fractional flow reserve: scientific basis. J Am Coll Cardiol. 2013 Jun 4;61(22):2233-41. doi: 10.1016/j.jacc.2012.11.083. Epub 2013 Apr 3.
PubMed 23562923Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
PubMed 8637515Legalery P, Schiele F, Seronde MF, Meneveau N, Wei H, Didier K, Blonde MC, Caulfield F, Bassand JP. One-year outcome of patients submitted to routine fractional flow reserve assessment to determine the need for angioplasty. Eur Heart J. 2005 Dec;26(24):2623-9. doi: 10.1093/eurheartj/ehi484. Epub 2005 Sep 1.
PubMed 16141256
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Correlation Between the Coronary Stenosis Degree With FFRCT and the Grade of Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT02802046
- Acronym / sponsor ID
- 42925078-2
- Conditions
- Coronary Stenosis, Angina Pectoris
- Keywords
- FFRCT, Angina pectoris grade, Fractional flow reserve, CCTA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guiyang No.4 People's HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- 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.
Angina pectoris is the most common clinical manifestation of coronary heart disease（CHD）, which is the main feature of chest pain caused by transient myocardial ischemia. Chronic stable angina pectoris is the degree, frequency, nature and cause of angina pectoris in patients with no significant change in a few weeks. The disease incidence is complex, difficult to diagnosis and treatment, clinical should be combined with various inspection methods for diagnosis and differential diagnosis. Fractional flow reserve of computerized tomographic scanning (FFRCT ) allows computerized tomographic scanning（CT） to scan the determination of coronary blood flow and blood pressure in the heart at rest and hyperemia, but no need to additional check or drugs. This technique has been used for noninvasive fractional flow reserve (FFR) in the calculation, assuming normal artery, calculated by the ratio of the maximum blood flow and blood flow of coronary artery stenosis of an artery. Along with the development and progress of computational fluid dynamics, in the resting state by computed tomographic angiography of coronary artery(CCTA) image data based, simulation of coronary artery maximal hyperemia and according to the 3-dimensional model of the traditional method of reconstruction of coronary arterial tree and ventricular muscle structure, and in order to calculated coronary blood flow and pressure. FFRCT is a novel non-invasive examination method, using computed tomographic angiography of coronary artery image data can be calculated FFR, and preliminary study proved that it has a high degree of correlation with traumatic FFR. Therefore, this study aims to evaluate the correlation between the degree of coronary stenosis and the grading of angina pectoris by noninvasive means --FFRCT, in order to provide a new idea for the diagnosis and differential diagnosis of coronary heart disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR≦0.8 | – | Radiation: Computed tomographic angiography of coronary arteryFFR is a score of 0 to 1, FFR < 0.75, has proved almost always accompanied by myocardial ischemia. |
| FFR>0.8 | – | Radiation: Computed tomographic angiography of coronary arteryFFR > 0.80 almost never associated with myocardial ischemia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From 2015 to 2017 in our hospital for clinical diagnosis of coronary heart disease and computed tomographic angiography of coronary artery(CCTA) examination of patients.
Key inclusion criteria (1 listed)
- After computed tomographic angiography of coronary artery (CCTA) for the diagnosis of coronary heart disease patients
Key exclusion criteria (1 listed)
- First, the patients with hematological diseases, infectious disease, end-stage renal disease and malignant tumor and other diseases. Second, the patients with acute myocardial infarction. Last, the percutaneous coronary intervention(PCI) and coronary artery bypass grafting (GABG) after the operation.
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 |
|---|---|---|
| Computed tomographic angiography of coronary artery | Radiation | FFR>0.8, FFR≦0.8 |
Primary outcome
FFR Value
Time frame: 1 years
1 secondary outcome
CCS Class
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Background: PubMed 23562923Taylor CA, Fonte TA, Min JK. Computational fluid dynamics applied to cardiac computed tomography for noninvasive quantification of fractional flow reserve: scientific basis. J Am Coll Cardiol. 2013 Jun 4;61(22):2233-41. doi: 10.1016/j.jacc.2012.11.083. Epub 2013 Apr 3.
- Background: PubMed 8637515Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
- Background: PubMed 16141256Legalery P, Schiele F, Seronde MF, Meneveau N, Wei H, Didier K, Blonde MC, Caulfield F, Bassand JP. One-year outcome of patients submitted to routine fractional flow reserve assessment to determine the need for angioplasty. Eur Heart J. 2005 Dec;26(24):2623-9. doi: 10.1093/eurheartj/ehi484. Epub 2005 Sep 1.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis and Angina Pectoris, run by Guiyang No.4 People's Hospital.
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 1 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 20 Jun 2016. 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 TAN Song, BSM ((0086)13885077912, masuigy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FFR Value (time frame: 1 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 NCT02802046, which also lists 3 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 20 Jun 2016.