Percutaneous Coronary InterventionPCINCT03614559
Contemporary Clinical Treatment and Long-term Outcomes in Patient With Coronary Chronic Total Occlusion
An observational study of Percutaneous Coronary Intervention, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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 … Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Percutaneous Coronary Intervention
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 :
- 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
Trial locations and contacts
1 site in 1 country.
Hao Cheng contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Lu Chen, Bachelor, 18321122021 ext. 18321122021, chen.lu1@zs-hospital.sh.cn
Hao Cheng, Bachelor, 15221113091
About this study
Official title: 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.
Read the 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)
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- chronic total occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after CAG
Secondary outcomes (1)
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
Measured: 2 years after CAG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start6 May 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614559
- Sponsor's protocol ID
- ZS-FDU-20180501
- Acronym
- PCI
- Status last verified
- Jul 2018
- First submitted
- 29 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemporary Clinical Treatment and Long-term Outcomes in Patient With Coronary Chronic Total Occlusion:"Time" is the Success Rate of PCI
- ClinicalTrials.gov ID
- NCT03614559
- Acronym / sponsor ID
- PCI / ZS-FDU-20180501
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- chronic total occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 6 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All CTO patients who has been diagnosed by coronary angiography in Shanghai Zhongshan Hospital in 2016-08-01 to 2017-07-31.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 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.
1 secondary outcome
Quality of life assessment
Time frame: 2 years after CAG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Cheng contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Chen (18321122021 ext. 18321122021, chen.lu1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiac and cerebrovascular events (MACCE) (time frame: 2 years after CAG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.