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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 :

  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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

    Lu Chen, Bachelor, 18321122021 ext. 18321122021, chen.lu1@zs-hospital.sh.cn

    Hao Cheng, Bachelor, 15221113091

    Recruiting

Other trials in China

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 :

  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)
Keywords
chronic total occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03614559
Study groupRoleWhat they receive
CTO PCI group and non CTO PCI groupCTO PCI group: Succession of CTO revascularization non CTO PCI group: Failure or not tried to revascularization
Initially attempted and re-attemptedPCI 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 notPCI during Chronic Total Occlusion Club, China Club : CAG in 2016.11.04 Another group: CAG in other time
Morning,Afternoon,NightMorning 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.

  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.

    Measured: 2 years after CAG

Secondary outcomes (1)
  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.

  1. First posted3 Aug 2018
  2. Study start6 May 2018
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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)
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

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.

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