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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03614559

Collaborator

(none)

2,000

Enrollment

Location

31.9

Anticipated Duration (Months)

62.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 :

Age ≥17 years old;
Finished coronary angiography(CAG) in Shanghai Zhongshan Hospital;
CAG found coronary artery(-ies) was/were total occluded more than 3 months;
CAG found the diameter of total occluded coronary artery was more than 2.5cm;

Exclude Criteria:

Cardiac arrest; Ventricular fibrillation; Cardiogenic shock; Acute thrombosis in the stent; Acute coronary syndrome;
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;
The diameter was too small or position was too distal of the total occluded coronary artery;
Combined severe hepatic or renal insufficiency;
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;
Pregnant, lactating women;
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:

Basic information: name, gender, age, hospital number, contact information;
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;
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;
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 Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 6, 2018

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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）

Outcome Measures

Primary Outcome Measures

Incidence of major adverse cardiac and cerebrovascular events (MACCE） [2 years after CAG]
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.

Secondary Outcome Measures

Quality of life assessment [2 years after CAG]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Entry Criteria :

Age ≥18 years old;
Finished coronary angiography(CAG) in Shanghai Zhongshan Hospital in 2016-08-01 to 2017-07-31;
CAG found coronary artery(-ies) was/were total occluded more than 3 months;
CAG found the diameter of total occluded coronary artery was more than 2.5cm;

Exclude Criteria:

Cardiac arrest; Ventricular fibrillation; Cardiogenic shock; Acute thrombosis in the stent; Acute coronary syndrome;
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;
The diameter was too small or position was too distal of the total occluded coronary artery;
Combined severe hepatic or renal insufficiency;
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;
Pregnant, lactating women;
Suffer from malignant tumor or life expectancy less than 2 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Junbo Ge, chief physician, Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT03614559

Other Study ID Numbers:

ZS-FDU-20180501

First Posted:

Aug 3, 2018

Last Update Posted:

Aug 14, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Junbo Ge, chief physician, Shanghai Zhongshan Hospital

chronic total occlusion

Study Results

No Results Posted as of Aug 14, 2018