Coronary Artery Ectasia
Conditions
Keywords
coronary artery ectasia, new classification, interventional therapy, coronary artery aneurysm
Brief 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.
Detailed 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.
Interventions
DEVICESingle BMS
Single bare metal stent covered the coronary artery aneurysm
DEVICESingle or Double BMS
Single or double layer bare metal stents covered the coronary artery aneurysm
DEVICEBMS+DES
Treated with bare metal stent combined with drug eluting stent
Sponsors
Beijing Chao Yang Hospital
Peking University People's Hospital
Hebei Medical University Fourth Hospital
China National Center for Cardiovascular Diseases
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebral events (MACCEs) | 6 months after treatment | Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in CCS grade | 6 months after treatment | Number of participants with CCS angina pectoris grade aggravated or alleviate |
| Changes in drug use | 6 months after treatment | Number of participants with increased the type or dose of anti-myocardial ischemia drugs |
| Changes in coronary artery aneurysm diameter | 6 months after treatment | Number of participants with coronary artery aneurysm diameter reduced, increased or unchanged |
Countries
China
Contacts
Primary ContactShubin Qiao, MD,PhD
Backup ContactZhuoxuan Yang, MD,PhD
Outcome results
None listed