Fractional Flow Reserve Derived From CT Related Treatment

NCT05319119 | Unknown

• 1 other identifier: BHe
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a retrospective, single-center study.This experiment aims to explore the influence of CT-FFR as a relevant for revascularization on the prognosis of patients with coronary heart disease, assessing concurrent on different basis the difference of prognosis of patients with revascularization was analyzed, and the significance of revascularization related by CT-FFR was analyzed.This study is a retrospective study. The treatment strategies of all patients are based on the results of CAG，including coronary revascularization.After calculating the CT-FFR value, the above doctors will formulate treatment strategies based on the results and formulate treatment strategies retrospectively.

Conditions

Coronary Angiography; Fractional Flow Reserve, Myocardial; Coronary Artery Disease

Keywords

Fractional Flow Reserve; CT-FFR; prognosis; coronary Revascularization

Outcome Measures

Primary Outcomes (1)

• All-cause death or Myocardial infarction

  Cardiovascular, non-cardiovascular and undetermined death or Target vessel related and non-target vessel related MI

  1 year

Secondary Outcomes (6)

• Heart failure

  1 year,2 years

• Non-target vessel revascularization

  1 year,2 years

• Cardiac death

  1 year,2 years

• Target vessel revascularization

  1 year,2 years

• Myocardial infarction

  1 year,2 years

Study Arms (2)

1.CT-FFR Related Group

Coronary diseased artery CTFFR\>80%, secondary prevention of coronary heart disease;Coronary diseased artery CTFFR≤80% revascularization at the lesion site and regular medication after PCI

Coronary Angiography Related Group

Coronary diseased artery CTFFR≤80%, coronary angiography decision does not require revascularization but apply coronary heart disease secondary prevention medication;Coronary diseased artery CTFFR\>80%,However, revascularization was performed according to conventional angiographic decisions and postoperative regular service was performed.For multivessel disease, although coronary revascularization is performed, there are still diseased artery with CTFFR≤80% and no revascularization is performed.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed or suspected coronary heart disease patients with typical symptoms or objective evidence of ischemia such as ECG, exercise treadmill, coronary CTA or CAG

You may qualify if:

• ①Diagnosed or suspected coronary heart disease patients during the diagnosis and treatment process
• From December 2017 to December 2020, coronary CTA and coronary artery CTA were performed simultaneously in Huazhong Fuwai Hospital.
• Patients with CAG (coronary CTA before coronary angiography after CAG, no more than 28 days apart).
• ③Age 18 to 75 years old.

You may not qualify if:

• ① The presence of severe artifact, dislocation or calcification in coronary CTA images affects FFRCT measurement. ② Contraindications to antiplatelet drugs
• Patients with acute myocardial infarction within 6 months④ PCI or CABG or heart transplantation and other operations that may affect the outcome ⑤ Severe heart failure⑥ Pregnant patients⑦ Combined tumor patients⑧ Life expectancy \< 2 years⑨ Have a history of other serious heart disease⑩ Contraindications for CAG⑪ Not suitable to participate in this researcher due to other reasons

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Gao, M.D

CONTACT

8613937165590; gaocy6802@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: March 29, 2022
• Primary Completion: April 6, 2022
• Study Completion: April 29, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-03

Locations

CN (1)