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

NCT03614559 | Unknown

• 1 other identifier: ZS-FDU-20180501
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention

Keywords

chronic total occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life assessment

  2 years after CAG

Study Arms (4)

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）

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Lu Chen

CONTACT

18321122021; chen.lu1@zs-hospital.sh.cn

Hao Cheng

CONTACT

15221113091

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 3, 2018
• Study Start: May 6, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 14, 2018

Record last verified: 2018-07

Locations

CN (1)