A New Classification and Interventional Therapy for Coronary Artery Ectasia (NCIPCAE)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Ectasia
• Intervention / Treatment: Device: Single BMS; Device: Single or Double BMS; Device: Single or Double BMS; Device: BMS+DES

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital
      • Contact: Zhuoxuan Yang, MD,PhD; Phone Number: +8618811756722; Email: 525599492@qq.com
      • Contact: Shubin Qiao, MD,PhD; Phone Number: +8613001237893; Email: qsbfw@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: coronary artery aneurysm with branches; The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, accompany with branches origin from the aneurysm	Device: Single BMS; Single bare metal stent covered the coronary artery aneurysm
Experimental: coronary artery aneurysm without branches; The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, without any branch origin from the aneurysm	Device: Single or Double BMS; Single or double layer bare metal stents covered the coronary artery aneurysm; Device: Single or Double BMS; Treated with single or double layer bare metal stents
Experimental: Coronary artery aneurysm with localized stenosis; The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, associated with severe stenosis of adjacent sites. localized stenosis defined as lesion to more than 70% stenosis and length less than 20 mm	Device: Single or Double BMS; Single or double layer bare metal stents covered the coronary artery aneurysm; Device: Single or Double BMS; Treated with single or double layer bare metal stents
Experimental: Coronary artery aneurysm with diffuse stenosis; The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, associated with severe stenosis of adjacent sites. Diffuse stenosis defined as lesion to more than 70% and length more than 20 mm	Device: BMS+DES; Treated with bare metal stent combined with drug eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in CCS grade	Number of participants with CCS angina pectoris grade aggravated or alleviate	6 months after treatment
Changes in drug use	Number of participants with increased the type or dose of anti-myocardial ischemia drugs	6 months after treatment
Changes in coronary artery aneurysm diameter	Number of participants with coronary artery aneurysm diameter reduced, increased or unchanged	6 months after treatment

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Peking University People's Hospital; Beijing Chao Yang Hospital; Hebei Medical University Fourth Hospital
• Investigators: Principal Investigator: Shubin Qiao, MD,PhD, Fuwai Hospital, Beijing, China

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: coronary artery aneurysm; coronary artery ectasia; new classification; interventional therapy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease; Aneurysm; Dilatation, Pathologic; Coronary Aneurysm
• Other Study ID Numbers: 2019XK320064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No