NCT02802046

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

2.7 years

First QC Date

June 13, 2016

Last Update Submit

June 16, 2016

Conditions

Keywords

FFRCTAngina pectoris gradeFractional flow reserveCCTA

Outcome Measures

Primary Outcomes (1)

  • FFR Value

    1 years

Secondary Outcomes (1)

  • CCS Class

    1 years

Study Arms (2)

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

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 23562923BACKGROUND
  • 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.

    PMID: 8637515BACKGROUND
  • 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.

    PMID: 16141256BACKGROUND

MeSH Terms

Conditions

Coronary StenosisAngina Pectoris

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

TANG Tingting, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director, Department of Radiology

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 16, 2016

Study Start

January 1, 2017

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

June 20, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share