Coronary AtherosclerosesNCT06542653
Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion
An observational study of Coronary Atheroscleroses, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Atheroscleroses
- What is being tested?
- PCI and OMT
- Type of treatment
- Surgery or procedure
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2023to 17 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery. The enrolled patients were divided into 2 groups, i.e., CTO-PCI group (n=187) and CTO-OMT group (n=46). The strategy to perform PCI on CTO patients was dependent on some factors, including co-morbidity, technical challenges, operators' preference
Who may be able to join
- patients with at least one coronary CTO lesion at our hospital in between January 2011 and December 2017
Who cannot join
- (1) patients with ST-segment elevation myocardial infarction (STEMI)
- (2)a history of coronary artery bypass grafting (CABG)
- (3) cardiogenic shock
- (4) malignant tumor. Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210009
Lei Jiang, +8618705501372, 2771248705@qq.com
Mei Wang, +8615256095215, 1513267113@qq.com
About this study
Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients.
Read the detailed description
patients with CTO lesions undergoing PCI at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2017 were enrolled. After someone were excluded due to CABG surgery, patients who met the enrollment criteria were divided into successful CTO-PCI group and CTO-OMT group based on the treatment received. The study primary endpoint was major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke. The secondary endpoint was all-cause death.
- Conditions
- Coronary Atheroscleroses
- Being tested
- PCI, OMT
- Keywords
- Chronic total occlusion, Percutaneous coronary intervention, Major adverse cardiovascular events
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Also called percutaneous coronary intervention
successful percutaneous coronary intervention (PCI) in Coronary chronic total occlusions (CTOs) patients
OMTDrug
Also called optimal medical therapy
optimal medical therapy (OMT) in CTO patients, such as aspirin 1td, ACEI/ARB 1td, β blocker 1td, statin 1td.
| Study group | Role | What they receive |
|---|---|---|
| CTO-PCI group | successful percutaneous coronary intervention (PCI) Receives: Procedure: PCI; Drug: OMT | |
| CTO-OMT group | optimal medical therapy (OMT) Receives: Drug: OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac cerebrovascular events (MACCE)
including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke.
Measured: January 2011 to December 2023
Secondary outcomes (1)
all-cause death
all-cause death
Measured: January 2011 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start17 Sep 2023
- Primary completion17 Sep 2024
- Study completion17 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Leilei, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Leilei Chen, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542653
- Sponsor's protocol ID
- CTO-PCI
- Status last verified
- Dec 2024
- First submitted
- 1 Aug 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion
- ClinicalTrials.gov ID
- NCT06542653
- Acronym / sponsor ID
- CTO-PCI
- Conditions
- Coronary Atheroscleroses
- Keywords
- Chronic total occlusion, Percutaneous coronary intervention, Major adverse cardiovascular events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 17 Sep 2023 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 17 Sep 2025 (estimated)
- First posted
- 7 Aug 2024 (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.
Coronary chronic total occlusions (CTOs) are considered to increase the risk of adverse clinical outcomes. The purpose of this study was to evaluate whether long-term clinical outcomes could be improved by successful percutaneous coronary intervention (PCI) over optimal medical therapy (OMT) in CTO patients.
Detailed description
patients with CTO lesions undergoing PCI at the First Affiliated Hospital of Nanjing Medical University from January 2011 to December 2017 were enrolled. After someone were excluded due to CABG surgery, patients who met the enrollment criteria were divided into successful CTO-PCI group and CTO-OMT group based on the treatment received. The study primary endpoint was major adverse cardiac cerebrovascular events (MACCE), including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke. The secondary endpoint was all-cause death.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTO-PCI group | – | Procedure: PCI, Drug: OMTsuccessful percutaneous coronary intervention (PCI) |
| CTO-OMT group | – | Drug: OMToptimal medical therapy (OMT) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery. The enrolled patients were divided into 2 groups, i.e., CTO-PCI group (n=187) and CTO-OMT group (n=46). The strategy to perform PCI on CTO patients was dependent on some factors, including co-morbidity, technical challenges, operators' preference
Key inclusion criteria (1 listed)
- patients with at least one coronary CTO lesion at our hospital in between January 2011 and December 2017
Key exclusion criteria (4 listed)
- (1) patients with ST-segment elevation myocardial infarction (STEMI)
- (2)a history of coronary artery bypass grafting (CABG)
- (3) cardiogenic shock
- (4) malignant tumor. Patients were referred for PCI based on CTO-related symptoms or evidence of viability, or corresponding ischemia in the area of the CTO artery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCIAlso: percutaneous coronary interventionsuccessful percutaneous coronary intervention (PCI) in Coronary chronic total occlusions (CTOs) patients | Procedure or surgery | CTO-PCI group |
| OMTAlso: optimal medical therapyoptimal medical therapy (OMT) in CTO patients, such as aspirin 1td, ACEI/ARB 1td, β blocker 1td, statin 1td. | Drug | CTO-OMT group, CTO-PCI group |
Primary outcome
major adverse cardiac cerebrovascular events (MACCE)
Time frame: January 2011 to December 2023
including cardiac death, recurrent myocardial infarction, unplanned revascularization, and stroke.
1 secondary outcome
all-cause death
Time frame: January 2011 to December 2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- 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.
Leilei Chen study director
The First Affiliated Hospital with Nanjing Medical University
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 Coronary Atheroscleroses, run by The First Affiliated Hospital with Nanjing Medical University 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?
The sponsor lists 1 inclusion and 4 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Wang (0086 15256095215, 1513267113@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac cerebrovascular events (MACCE) (time frame: January 2011 to December 2023). 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 27 Dec 2024.