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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04265989
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Beijing Chao Yang Hospital
Peking University People's Hospital
Hebei Medical University Fourth Hospital
Information provided by (Responsible Party):
Shubin_Qiao, China National Center for Cardiovascular Diseases

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Ectasia Device: Single BMS Device: Single or Double BMS Device: BMS+DES Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A New Classification and Interventional Therapy for Coronary Artery Ectasia
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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

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
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




Primary Outcome Measures :
  1. Major adverse cardiac and cerebral events (MACCEs) [ Time Frame: 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 Outcome Measures :
  1. Changes in CCS grade [ Time Frame: 6 months after treatment ]
    Number of participants with CCS angina pectoris grade aggravated or alleviate

  2. Changes in drug use [ Time Frame: 6 months after treatment ]
    Number of participants with increased the type or dose of anti-myocardial ischemia drugs

  3. Changes in coronary artery aneurysm diameter [ Time Frame: 6 months after treatment ]
    Number of participants with coronary artery aneurysm diameter reduced, increased or unchanged



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265989


Contacts
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Contact: Shubin Qiao, MD,PhD +8613701237893 qsbfw@sina.com
Contact: Zhuoxuan Yang, MD,PhD +8618811756722 525599492@qq.com

Locations
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China, Beijing
Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Shubin Qiao, MD,PhD    +8613001237893    qsbfw@sina.com   
Contact: Zhuoxuan Yang, MD,PhD    +8618811756722    525599492@qq.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Beijing Chao Yang Hospital
Peking University People's Hospital
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: Shubin Qiao, MD,PhD Fuwai Hospital, Beijing, China

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Responsible Party: Shubin_Qiao, Director,Head of cardiology department, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT04265989    
Other Study ID Numbers: 2019XK320064
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shubin_Qiao, China National Center for Cardiovascular Diseases:
coronary artery ectasia
new classification
interventional therapy
coronary artery aneurysm
Additional relevant MeSH terms:
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Coronary Aneurysm
Dilatation, Pathologic
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Aneurysm
Vascular Diseases