Clinical trial NCT04265989: A New Classification and Interventional Therapy for Coronary Artery Ectasia
Official title: A New Classification and Interventional Therapy for Coronary Artery Ectasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Ectasia
Keywords: coronary artery ectasia
new classification
interventional therapy
coronary artery aneurysm
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Chao Yang Hospital
name: Peking University People's Hospital
name: Hebei Medical University Fourth Hospital
First posted: 2020-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac and cerebral events (MACCEs)
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Changes in CCS grade
timeFrame: 6 months after treatment
measure: Changes in drug use
timeFrame: 6 months after treatment
measure: Changes in coronary artery aneurysm diameter
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Beijing, China
name: Shubin Qiao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: