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Critical Treatment of Coronary Artery Disease (CTCAD)

Primary Purpose

Coronary Artery Disease, Coronary Artery Disease Progression

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stent implantation
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Critical lesion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Zhongda Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional therapy group

Conservative treatment group

Arm Description

Outcomes

Primary Outcome Measures

Major cardiovascular adverse events
Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis

Secondary Outcome Measures

Chest pain
Frequency of angina pectoris

Full Information

First Posted
June 21, 2017
Last Updated
April 12, 2023
Sponsor
Southeast University, China
Collaborators
Science and Technology Department of Jiangsu Province
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1. Study Identification

Unique Protocol Identification Number
NCT03195621
Brief Title
Critical Treatment of Coronary Artery Disease
Acronym
CTCAD
Official Title
Treatment Strategy for Critical Lesions of Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
Collaborators
Science and Technology Department of Jiangsu Province

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Disease Progression
Keywords
Coronary Artery Disease, Critical lesion

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional therapy group
Arm Type
Experimental
Arm Title
Conservative treatment group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Stent implantation
Intervention Description
Stent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions.
Primary Outcome Measure Information:
Title
Major cardiovascular adverse events
Description
Cardiac death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis
Time Frame
one year after enrollment
Secondary Outcome Measure Information:
Title
Chest pain
Description
Frequency of angina pectoris
Time Frame
one year after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gen-shan Ma, Ph.D
Organizational Affiliation
Southeast University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
320000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We do not decide whether to share individual participant data

Learn more about this trial

Critical Treatment of Coronary Artery Disease

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