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Critical Treatment of Coronary Artery Disease (CTCAD)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195621
Recruitment Status : Unknown
Verified June 2017 by Genshan Ma, Southeast University, China.
Recruitment status was:  Recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Science and Technology Department of Jiangsu Province
Information provided by (Responsible Party):
Genshan Ma, Southeast University, China

Brief Summary:
Identifying the critical lesion of coronary artery disease and determining the interventional plan are significant for reducing adverse cardiovascular adverse events. The assessment of critical lesion requires the consideration of plaque morphology, tissue composition, and endometrial stress which leading to rupture. In summary, accurate assessment of critical lesions has high application value. In this study, patients with critical coronary artery disease were divided into two groups: an accurate assessment group and a simple assessment group, with the aim to compare the diagnosis and treatment efficiency as well as prognosis, potential cardiovascular risk, possible "excessive" intervention.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Disease Progression Device: Stent implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Treatment Strategy for Critical Lesions of Coronary Artery Disease
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional therapy group Device: Stent implantation
Stent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions.

No Intervention: Conservative treatment group



Primary Outcome Measures :
  1. Major cardiovascular adverse events [ Time Frame: one year after enrollment ]
    Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis


Secondary Outcome Measures :
  1. Chest pain [ Time Frame: one year after enrollment ]
    Frequency of angina pectoris



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Volunteered to participate in this study and signed an informed consent form;

Men or non-pregnant women ≥ 18 and ≤80 years of age;

Lesion is located in a coronary artery and stenosis is between 50-75%;

Exclusion Criteria:

Severe liver and kidney diseases (GFR<60 ml/min/1.73m2 or CTP≥6 score);

Moderate to severe hypertension (after standard antihypertensive therapy, blood pressure higher than 160/100mmHg);

Patients with hemodynamic or electrical instability (including shock);

Coagulation disorders associated with significant bleeding tendency (eg, hypersensitivity, active bleeding, moderate or severe liver disease, GI bleed within the past 6 months, major surgery within 30 days);

Patients with ischemic stroke within one week;

Any contraindication against the use of anti-platelet drugs such as aspirin;

Platelet count less than 100 x 109/L, haemoglobin (Hb) level less than 100 g/L;

Researchers involved in the study and / or immediate family members;

Participation in another investigation drug or device study in the past 30 days before enrollment;

Involvement in the planning and conduct of the study (applies to staffs at study sites);

Suffering from serious arrhythmias include recurrent ventricular tachycardia or ventricular fibrillation;

Pregnancy or lactation or females of child-bearing potential with the plan of pregnancy in one year;


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): NCT03195621


Contacts
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Contact: Wen-bin Lu, Ph.D 025-83262565 luwenbinseu@163.com
Contact: Jian Zhu, Ph.D 025-83262596 njzhujian@163.com

Locations
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China, Jiangsu
Zhongda Hospital Recruiting
Nanjing, Jiangsu, China, 320000
Contact: Wen-bin Lu, Ph.D    025-83262595    luwenbinseu@163.com   
Contact: Jian Zhu, Ph.D    025-83262596    njzhujian@163.com   
Sponsors and Collaborators
Southeast University, China
Science and Technology Department of Jiangsu Province
Investigators
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Study Director: Gen-shan Ma, Ph.D Southeast University

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Responsible Party: Genshan Ma, Director of cardiology, Southeast University, China
ClinicalTrials.gov Identifier: NCT03195621     History of Changes
Other Study ID Numbers: BE2016785
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We do not decide whether to share individual participant data

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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 Genshan Ma, Southeast University, China:
Coronary Artery Disease
Critical lesion
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Disease Progression
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes