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

Primary Purpose

Coronary Artery Ectasia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Single BMS
Single or Double BMS
Single or Double BMS
BMS+DES
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Ectasia focused on measuring coronary artery ectasia, new classification, interventional therapy, coronary artery aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

coronary artery aneurysm with branches

coronary artery aneurysm without branches

Coronary artery aneurysm with localized stenosis

Coronary artery aneurysm with diffuse stenosis

Arm Description

The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, accompany with branches origin from the aneurysm

The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, without any branch origin from the aneurysm

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in CCS grade
Number of participants with CCS angina pectoris grade aggravated or alleviate
Changes in drug use
Number of participants with increased the type or dose of anti-myocardial ischemia drugs
Changes in coronary artery aneurysm diameter
Number of participants with coronary artery aneurysm diameter reduced, increased or unchanged

Full Information

First Posted
February 10, 2020
Last Updated
February 12, 2020
Sponsor
China National Center for Cardiovascular Diseases
Collaborators
Beijing Chao Yang Hospital, Peking University People's Hospital, Hebei Medical University Fourth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04265989
Brief Title
A New Classification and Interventional Therapy for Coronary Artery Ectasia
Acronym
NCIPCAE
Official Title
A New Classification and Interventional Therapy for Coronary Artery Ectasia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases
Collaborators
Beijing Chao Yang Hospital, Peking University People's Hospital, Hebei Medical University Fourth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Ectasia
Keywords
coronary artery ectasia, new classification, interventional therapy, coronary artery aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
coronary artery aneurysm with branches
Arm Type
Experimental
Arm Description
The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, accompany with branches origin from the aneurysm
Arm Title
coronary artery aneurysm without branches
Arm Type
Experimental
Arm Description
The diameter of coronary artery aneurysm is more than 5mm and less than 10mm, without any branch origin from the aneurysm
Arm Title
Coronary artery aneurysm with localized stenosis
Arm Type
Experimental
Arm Description
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
Arm Title
Coronary artery aneurysm with diffuse stenosis
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Single BMS
Intervention Description
Single bare metal stent covered the coronary artery aneurysm
Intervention Type
Device
Intervention Name(s)
Single or Double BMS
Intervention Description
Single or double layer bare metal stents covered the coronary artery aneurysm
Intervention Type
Device
Intervention Name(s)
Single or Double BMS
Intervention Description
Treated with single or double layer bare metal stents
Intervention Type
Device
Intervention Name(s)
BMS+DES
Intervention Description
Treated with bare metal stent combined with drug eluting stent
Primary Outcome Measure Information:
Title
Major adverse cardiac and cerebral events (MACCEs)
Description
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
Changes in CCS grade
Description
Number of participants with CCS angina pectoris grade aggravated or alleviate
Time Frame
6 months after treatment
Title
Changes in drug use
Description
Number of participants with increased the type or dose of anti-myocardial ischemia drugs
Time Frame
6 months after treatment
Title
Changes in coronary artery aneurysm diameter
Description
Number of participants with coronary artery aneurysm diameter reduced, increased or unchanged
Time Frame
6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shubin Qiao, MD,PhD
Phone
+8613701237893
Email
qsbfw@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuoxuan Yang, MD,PhD
Phone
+8618811756722
Email
525599492@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shubin Qiao, MD,PhD
Organizational Affiliation
Fuwai Hospital, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shubin Qiao, MD,PhD
Phone
+8613001237893
Email
qsbfw@sina.com
First Name & Middle Initial & Last Name & Degree
Zhuoxuan Yang, MD,PhD
Phone
+8618811756722
Email
525599492@qq.com

12. IPD Sharing Statement

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A New Classification and Interventional Therapy for Coronary Artery Ectasia

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