A New Classification and Interventional Therapy for Coronary Artery Ectasia

Coronary Artery Ectasia Clinical Trial

— NCIPCAE  

Official title:

A New Classification and Interventional Therapy for Coronary Artery Ectasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265989
• Other study ID #: 2019XK320064
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2020
• Source: China National Center for Cardiovascular Diseases
• Contact: Shubin Qiao, MD,PhD
• Phone: +8613701237893
• Email: qsbfw[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aim to present a new classification for coronary artery ectasia and find the best interventional therapy for different types of patients were treated and studied.

Description:

Coronary artery ectasia refers to a variety of reasons cause coronary artery expansion, its diameter is more than 1.5 times that of the adjacent normal coronary artery. Clinical symptoms include angina, myocardial infarction and sudden death.At present, there is no consensus on the mechanism and treatment of the disease, which may be related to the structural failure of the vessel wall and abnormal hemodynamics in the dilated segment.Most of the existing studies are case reports or single-center retrospective analysis of small samples, with low level of evidence.As a common fluid analysis method in the field of engineering, computational fluid dynamics can effectively simulate the movement and stress state of blood under reasonable model assumptions.By comparing the preoperative and postoperative data of real cases, the validity of simulation analysis results can be tested.The purpose of this study is to carry out a multi-center study combining morphological and hemodynamic factors, to propose a new classification and interventional treatment strategy for atherosclerotic coronary artery ectasia, and to provide evidence-based medical evidence for the development of treatment guidelines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or non-pregnant female aged =18 years;

• Coronary artery ectasia was confirmed by coronary CT or coronary angiography;

• The patient (or guardian) is fully aware of the study process and signs the informed consent;

• Patients were able to undergo subsequent follow-up.

Exclusion Criteria:

• Congenital coronary artery fistula;

• kawasaki disease;

• Treponema pallidum or lyme treponema;

• Marfan;

• Primary lymphoma;

• Coronary artery pseudoaneurysm;

• Acute infectious disease or autoimmune disease;

• Hematological Disease;

• Severe liver and kidney dysfunction (AMI one week later, alanine transaminase =3 times the upper limit of normal value; Creatinine clearance rate =30ml/min or blood creatinine =2.5mg/dl);

• Unstable craniocerebral disease;

• Cancer;

• Severe cognitive impairment (dementia or severe mental illness);

• Patients with severe physical disabilities who cannot be followed up regularly;

• Other serious uncontrolled systemic diseases;

• Female patient who is ready to become pregnant, already pregnant or nursing;

• Contraindications to percutaneous coronary intervention (PCI) : for patients at high risk of massive bleeding in the digestive tract, intracranial and other areas, or allergic to contrast agents;

• Cannot tolerate dual antiplatelet therapy for at least 1 year;

• Age < 18 years old;

• Patients who are unable or unwilling to sign informed consent

Related Conditions & MeSH terms

• Coronary Aneurysm
• Coronary Artery Ectasia

Intervention

Device:
• Single BMS
Single bare metal stent covered the coronary artery aneurysm
• Single or Double BMS
Single or double layer bare metal stents covered the coronary artery aneurysm
• Single or Double BMS
Treated with single or double layer bare metal stents
• BMS+DES
Treated with bare metal stent combined with drug eluting stent

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Beijing Chao Yang Hospital, Hebei Medical University Fourth Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebral events (MACCEs)	Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization	6 months after treatment
Secondary	Changes in CCS grade	Number of participants with CCS angina pectoris grade aggravated or alleviate	6 months after treatment
Secondary	Changes in drug use	Number of participants with increased the type or dose of anti-myocardial ischemia drugs	6 months after treatment
Secondary	Changes in coronary artery aneurysm diameter	Number of participants with coronary artery aneurysm diameter reduced, increased or unchanged	6 months after treatment