Evaluation of the Correlation Between the Coronary Stenosis Degree With FFRCT and the Grade of Stable Angina Pectoris

Angina Pectoris Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02802046
• Other study ID #: 42925078-2
• Status: Not yet recruiting
• Phase: N/A
• First received: June 13, 2016
• Last updated: June 16, 2016
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: June 2016
• Source: Guiyang No.4 People's Hospital
• Contact: TAN Song, BSM
• Phone: (0086)13885077912
• Email: masuigy[@]163.com
• Is FDA regulated: No
• Health authority: China: Guiyang municipal health and Family Planning Commission
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• After computed tomographic angiography of coronary artery (CCTA) for the diagnosis of coronary heart disease patients

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Stenosis

Intervention

Radiation:
• Computed tomographic angiography of coronary artery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guiyang No.4 People's Hospital

References & Publications (3)

Legalery 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. Epub 2005 Sep 1. — View Citation

Pijls 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FFR Value		1 years	No
Secondary	CCS Class		1 years	No