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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04265989
Other study ID # 2019XK320064
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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