Contemporary Clinical Treatment and Long-term Outcomes in Patient With Coronary Chronic Total Occlusion

NCT ID: NCT03614559

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-06
• Study Completion Date: 2020-12-31

Brief Summary

In order to know more about contemporary clinical treatment ,epidemiological characteristics, and long-term outcomes in patients with Coronary Chronic Total Occlusion（CTO）in China, the study through collecting and effective analyzing basic information, cardiovascular characteristics, contemporary clinical treatment , and long-term outcomes of CTO patients ,to describe the relevant risk factors ,the contemporary incidence of CTOs and the success rates of CTO percutaneous coronary intervention (PCI), as well as the complications and long-term outcomes of these patients, to explore the relevant factors which affecting the success rates of PCI therapy and to provide safer and more effective advice for the treatment of CTO.

Detailed Description

Study Center : Shanghai Zhongshan Hospital

Study Purpose : Through collecting and effective analyzing basic information, cardiovascular characteristics, contemporary clinical treatment , and long-term outcomes of CTO patients ,to describe the relevant risk factors ,the contemporary incidence of CTOs and the success rates of CTO percutaneous coronary intervention (PCI), as well as the complications and long-term outcomes of these patients, to explore the relevant factors which affecting the success rates of PCI therapy and to provide safer and more effective advice for the treatment of CTO.

Study Design : A Retrospective Observational Study

Study Population Description : All CTO patients who has been diagnosed by coronary angiography in Shanghai Zhongshan Hospital in 2016-08-01 to 2020-12-31

Eligibility Criteria :

Entry Criteria :

1. Age ≥17 years old;

2. Finished coronary angiography(CAG) in Shanghai Zhongshan Hospital;

3. CAG found coronary artery(-ies) was/were total occluded more than 3 months;

4. CAG found the diameter of total occluded coronary artery was more than 2.5cm;

Exclude Criteria:

1. Cardiac arrest; Ventricular fibrillation; Cardiogenic shock; Acute thrombosis in the stent; Acute coronary syndrome;

2. The bridge vessel(-s) was/were not total occluded and coronary artery(-ies) was/were total occluded but not trying to revascularize in CAG of the patient who has gone through coronary artery bypass graft before;

3. The diameter was too small or position was too distal of the total occluded coronary artery;

4. Combined severe hepatic or renal insufficiency;

5. The patient who has history of major surgical, cerebral hemorrhage, severe gastrointestinal bleeding, severe anemia, severe allergies, and other anti-platelet drug contraindications in recent 3 months;

6. Pregnant, lactating women;

7. Suffer from malignant tumor or life expectancy less than 2 years

Sample size :

Collecting all cases of CTO patient who has been diagnosed in 2016-08-01 to 2020-12-31 and comply with entry and exclude standards, the expectation of quantity is about 3000-4000.

Follow up time： 2 years

Information collection:

1. Basic information: name, gender, age, hospital number, contact information;

2. Relevant risk factors: medication history, smoking history, drinking history, history of hypertension, history of diabetes, history of dyslipidemia, history of arrhythmia, history of cerebrovascular disease, history of renal insufficiency, previous coronary CTA, and previous myocardial infarction, previous PCI and time, previous CABG surgery and time;

3. Cardiovascular information: Preoperative and postoperative BNP, preoperative and postoperative cTnT, cardiac ultrasonography and LVEF, total occluded coronary artery, collateral circulation establishment, J-CTO score, Progress score, PCI operation mode, contrast agent usage, and final treatment plan;

4. Follow-up content: short-term results (perioperative-related complications) and 2-year long-term results (cardiac and LVEF, cardiac death, re-hospitalization of acute myocardial infarction, and subsequent CABG surgery)

Conditions

Percutaneous Coronary Intervention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

CTO PCI group and non CTO PCI group

CTO PCI group： Succession of CTO revascularization non CTO PCI group： Failure or not tried to revascularization

No interventions assigned to this group

Initially attempted and re-attempted

PCI initially attempted group： First time to try to revascularization PCI re-attempted group: Second or more time to try to revascularization

No interventions assigned to this group

PCI during China Club or not

PCI during Chronic Total Occlusion Club， China Club : CAG in 2016.11.04 Another group: CAG in other time

No interventions assigned to this group

Morning，Afternoon，Night

Morning group:（8:00-12:59） Afternoon group：（13:00-17:59） Night group：（after 18:00）

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Entry Criteria :

1. Age ≥18 years old;

2. Finished coronary angiography(CAG) in Shanghai Zhongshan Hospital in 2016-08-01 to 2017-07-31;

3. CAG found coronary artery(-ies) was/were total occluded more than 3 months;

4. CAG found the diameter of total occluded coronary artery was more than 2.5cm;

Exclude Criteria:

1. Cardiac arrest; Ventricular fibrillation; Cardiogenic shock; Acute thrombosis in the stent; Acute coronary syndrome;

2. The bridge vessel(-s) was/were not total occluded and coronary artery(-ies) was/were total occluded but not trying to revascularize in CAG of the patient who has gone through coronary artery bypass graft before;

3. The diameter was too small or position was too distal of the total occluded coronary artery;

4. Combined severe hepatic or renal insufficiency;

5. The patient who has history of major surgical, cerebral hemorrhage, severe gastrointestinal bleeding, severe anemia, severe allergies, and other anti-platelet drug contraindications in recent 3 months;

6. Pregnant, lactating women;

7. Suffer from malignant tumor or life expectancy less than 2 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junbo Ge

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lu Chen

Role: CONTACT

chen.lu1@zs-hospital.sh.cn

18321122021 ext. 18321122021

Hao Cheng

Role: CONTACT

15221113091

Facility Contacts

Lu Chen, Bachelor

Role: primary

chen.lu1@zs-hospital.sh.cn

18321122021 ext. 18321122021

Hao Cheng, Bachelor

Role: backup

15221113091

Other Identifiers

ZS-FDU-20180501

Identifier Type: -

Identifier Source: org_study_id