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

Contemporary Clinical Treatment and Long-term Outcomes in Patient With Coronary Chronic Total Occlusion："Time" is the Success Rate of PCI

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.

Study Overview

• Status: Unknown
• Conditions: Percutaneous Coronary Intervention

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)

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Lu Chen; Phone Number: 18321122021 18321122021; Email: chen.lu1@zs-hospital.sh.cn
• Study Contact Backup: Name: Hao Cheng; Phone Number: 15221113091

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital
      • Principal Investigator: Junbo Ge, M.D.
      • Contact: Lu Chen, Bachelor; Phone Number: 18321122021 18321122021; Email: chen.lu1@zs-hospital.sh.cn
      • Contact: Hao Cheng, Bachelor; Phone Number: 15221113091
      • Sub-Investigator: Jianying Ma, M.D.
      • Sub-Investigator: Lu Chen, Bachelor
      • Sub-Investigator: Hao Cheng, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All CTO patients who has been diagnosed by coronary angiography in Shanghai Zhongshan Hospital in 2016-08-01 to 2017-07-31.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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
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
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
Morning，Afternoon，Night; Morning group:（8:00-12:59） Afternoon group：（13:00-17:59） Night group：（after 18:00）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse cardiac and cerebrovascular events (MACCE）	MACCE, including any of the following adverse events before hospital discharge: death from any cause, Q-wave myocardial infarction, recurrent symptoms Heart and Vessels requiring urgent repeat target vessel revascularization with PCI or CABG, tamponade requiring either pericardiocentesis or surgery, and stroke.	2 years after CAG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment	Two years after having CAG ， we may talk to patient face to face or by phone to help them finish the Seattle Angina Questionnaire （SAQ），measure the score of SAQ and assess the quality of life	2 years after CAG

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 29, 2018
• First Submitted That Met QC Criteria: July 29, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: chronic total occlusion
• Other Study ID Numbers: ZS-FDU-20180501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No