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

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 Overview

• Status: Unknown
• Conditions: Angina Pectoris; Coronary Stenosis
• Intervention / Treatment: Radiation: Computed tomographic angiography of coronary artery

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: TAN Song, BSM; Phone Number: (0086)13885077912; Email: masuigy@163.com
• Study Contact Backup: Name: TANG Tingting, MD; Phone Number: (0086)13984022759; Email: 728677395@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FFR≦0.8; FFR is a score of 0 to 1, FFR < 0.75, has proved almost always accompanied by myocardial ischemia.	Radiation: Computed tomographic angiography of coronary artery
FFR>0.8; FFR > 0.80 almost never associated with myocardial ischemia.	Radiation: Computed tomographic angiography of coronary artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FFR Value	1 years

Secondary Outcome Measures

Outcome Measure	Time Frame
CCS Class	1 years

Collaborators and Investigators

• Sponsor: Guiyang No.4 People's Hospital

Publications and helpful links

General Publications

• 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. doi: 10.1056/NEJM199606273342604.
• 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.
• 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. doi: 10.1093/eurheartj/ehi484. Epub 2005 Sep 1.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Estimate): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Fractional flow reserve; CCTA; FFRCT; Angina pectoris grade
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Coronary Disease; Chest Pain; Constriction, Pathologic; Angina Pectoris; Coronary Stenosis
• Other Study ID Numbers: 42925078-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO