Chronic Total Occlusion of Coronary ArteryCOLLECTNCT06054126
COronary CoLLateralization in Type 2 diabEtic Patients With Chronic Total Occlusion
An observational study of Chronic Total Occlusion of Coronary Artery and Diabetes Mellitus, Type 2, run by Ruijin Hospital at 1 site in China.
Trial summary
A severe coronary artery obstruction is a prerequisite for spontaneous collateral recruitment. The formation of coronary collateral circulation(CCC) is significantly impaired in type 2 diabetic patients with chronic total occlusion (CTO) compared with non-diabetic patients with CTO. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery, Diabetes Mellitus, Type 2
- What is being tested?
- Echocardiography
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 1 Mar 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetic patients with chronic total occlusion undergone coronary angiography at Ruijin Hospital, Shanghai, China are consecutively enrolled.
Who may be able to join
- Age 18-90 years
- Type 2 diabetes diagnosed by one of the following criteria:
- HbA1c >/= 6.5% Fasting plasma glucose >/= 7.0 mmol/l (confirmed) 2h plasma glucose value during OGTT >/= 11.1 mmol/l Already receiving glucose-lowering agents.
- At least one lesion with angiographic total occlusion
Who cannot join
- eGFR<15mL/(min·1.73m2)
- chronic heart failure with NYHA grade ≥3
- had a history of coronary artery bypass grafting
- had received a percutaneous coronary intervention within the prior 3 months
- Malignant tumor or immune system disorders
- Pulmonary heart disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Ying Shen, 18601683266, rjshenying@qq.com
About this study
Official title: The Development of Coronary Collateralization in Type 2 Diabetic Patients With Chronic Total Occlusion
A severe coronary artery obstruction is a prerequisite for spontaneous collateral recruitment. The formation of coronary collateral circulation(CCC) is significantly impaired in type 2 diabetic patients with chronic total occlusion (CTO) compared with non-diabetic patients with CTO. This retrospective cohort enrolls consecutive T2DM patients who had at least one lesion with coronary angiographic total occlusion.
Read the detailed description
COronary CoLLateralization in Type 2 diabEtic Patients With Chronic Total Occlusion (COLLECT) study is a single center, retrospective cohort study to investigate potential factors associated with the development of coronary collateral circulation in diabetic patients. Investigators will consecutively enroll T2DM patients who had at least one lesion with coronary angiographic total occlusion. The development of coronary collateral circulation will be graded according to the Rentrop method and patients will be divided into poor CCC (grade 0 or 1) or good (grade 2 or 3) CCC groups according to their Rentrop grades. Baseline clinical and laboratory characteristics at hospital admission will be recorded to analyze potential factors associated with the development of coronary collateral circulation in T2DM patients with CTO. Later, their cardiac function will be evaluated by echocardiography at one year follow-up.
- Being tested
- Echocardiography
- Keywords
- Atherosclerosis, Diabetes Mellitus, Type 2, Chronic Total Occlusion of Coronary Artery, Coronary artery disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Atherosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Cardiac function was evaluated by echocardiography at one year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| T2DM with good CCC | T2DM was diagnosed according to the criteria of the American Diabetes Association. The diagnosis of CTO was made if at least one lesion was angiographic 100% occlusion. Coronary collateral circulation development was graded according to the Cohen-Rentrop method, grade 2 (partial filling of the epicardial segment by collateral vessels); grade 3 (complete filling of the epicardial artery by collateral vessels) were defined as good coronary collateral circulation. Receives: Other: Echocardiography | |
| T2DM with poor CCC | T2DM was diagnosed according to the criteria of the American Diabetes Association. The diagnosis of CTO was made if at least one lesion was angiographic 100% occlusion. Coronary collateral circulation development was graded according to the Cohen-Rentrop method, grade 0 (no filling of any collateral vessels) and grade 1 (filling of side branches of the artery to be perfused by collateral vessels without visualization of the epicardial segment) were defined as poor coronary collateral circulation. Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function evaluated by echocardiography
Assessed by echocardiography
Measured: 12 months
Secondary outcomes (1)
Cardiovascular events
The incidence of MACCE (major adverse cardiac and cerebrovascular events)
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Jan 2010
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054126
- Sponsor's protocol ID
- sy11218
- Acronym
- COLLECT
- Status last verified
- Aug 2023
- First submitted
- 19 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mao LS, Wang YX, Qi Y, Yue ZR, Ding FH, Wang XQ, Lu L, Shen WF, Shen Y. Elevated Uric Acid/Albumin Ratio Predicts Poor Coronary Collateral Circulation in Type 2 Diabetic Patients With Stable Coronary Artery Disease. J Diabetes Res. 2025 Dec 19;2025:9721061. doi: 10.1155/jdr/9721061. eCollection 2025.
PubMed 41497488Chen Q, Liu J, Madonna R, Li F, Chen S, Li L, Wu X, Maimati Y, Ding F, Wang X, Shen Y, Zhang R, Shen W, Dai Y, Lu L, De Caterina R. Vasostatin-2 attenuates injury-induced neointimal hyperplasia through the ACE2/MasR/PPARgamma/NR1D1/Gas1 axis. Cardiovasc Res. 2025 Nov 22;121(14):2260-2277. doi: 10.1093/cvr/cvaf192.
PubMed 41231769Mao LS, Geng L, Wang YX, Qi Y, Wang MH, Ding FH, Dai Y, Lu L, Zhang Q, Shen WF, Shen Y. Clinical risk score to predict poor coronary collateralization in type 2 diabetic patients with chronic total occlusion. BMC Cardiovasc Disord. 2025 Apr 2;25(1):250. doi: 10.1186/s12872-025-04687-8.
PubMed 40175898
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Coronary Collateralization in Type 2 Diabetic Patients With Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT06054126
- Acronym / sponsor ID
- COLLECT / sy11218
- Keywords
- Atherosclerosis, Diabetes Mellitus, Type 2, Chronic Total Occlusion of Coronary Artery, Coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 26 Sep 2023 (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.
A severe coronary artery obstruction is a prerequisite for spontaneous collateral recruitment. The formation of coronary collateral circulation(CCC) is significantly impaired in type 2 diabetic patients with chronic total occlusion (CTO) compared with non-diabetic patients with CTO. This retrospective cohort enrolls consecutive T2DM patients who had at least one lesion with coronary angiographic total occlusion.
Detailed description
COronary CoLLateralization in Type 2 diabEtic Patients With Chronic Total Occlusion (COLLECT) study is a single center, retrospective cohort study to investigate potential factors associated with the development of coronary collateral circulation in diabetic patients. Investigators will consecutively enroll T2DM patients who had at least one lesion with coronary angiographic total occlusion. The development of coronary collateral circulation will be graded according to the Rentrop method and patients will be divided into poor CCC (grade 0 or 1) or good (grade 2 or 3) CCC groups according to their Rentrop grades. Baseline clinical and laboratory characteristics at hospital admission will be recorded to analyze potential factors associated with the development of coronary collateral circulation in T2DM patients with CTO. Later, their cardiac function will be evaluated by echocardiography at one year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM with good CCC | – | Other: EchocardiographyT2DM was diagnosed according to the criteria of the American Diabetes Association. The diagnosis of CTO was made if at least one lesion was angiographic 100% occlusion. Coronary collateral circulation development was graded according to the Cohen-Rentrop method, grade 2 (partial filling of the epicardial segment by collateral vessels); grade 3 (complete filling of the epicardial artery by collateral vessels) were defined as good coronary collateral circulation. |
| T2DM with poor CCC | – | Other: EchocardiographyT2DM was diagnosed according to the criteria of the American Diabetes Association. The diagnosis of CTO was made if at least one lesion was angiographic 100% occlusion. Coronary collateral circulation development was graded according to the Cohen-Rentrop method, grade 0 (no filling of any collateral vessels) and grade 1 (filling of side branches of the artery to be perfused by collateral vessels without visualization of the epicardial segment) were defined as poor coronary collateral circulation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients with chronic total occlusion undergone coronary angiography at Ruijin Hospital, Shanghai, China are consecutively enrolled.
Key inclusion criteria (4 listed)
- Age 18-90 years
- Type 2 diabetes diagnosed by one of the following criteria:
- HbA1c >/= 6.5% Fasting plasma glucose >/= 7.0 mmol/l (confirmed) 2h plasma glucose value during OGTT >/= 11.1 mmol/l Already receiving glucose-lowering agents.
- At least one lesion with angiographic total occlusion
Key exclusion criteria (6 listed)
- eGFR<15mL/(min·1.73m2)
- chronic heart failure with NYHA grade ≥3
- had a history of coronary artery bypass grafting
- had received a percutaneous coronary intervention within the prior 3 months
- Malignant tumor or immune system disorders
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 |
|---|---|---|
| EchocardiographyCardiac function was evaluated by echocardiography at one year follow-up. | Other | T2DM with good CCC, T2DM with poor CCC |
Primary outcome
Cardiac function evaluated by echocardiography
Time frame: 12 months
Assessed by echocardiography
1 secondary outcome
Cardiovascular events
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 41497488Mao LS, Wang YX, Qi Y, Yue ZR, Ding FH, Wang XQ, Lu L, Shen WF, Shen Y. Elevated Uric Acid/Albumin Ratio Predicts Poor Coronary Collateral Circulation in Type 2 Diabetic Patients With Stable Coronary Artery Disease. J Diabetes Res. 2025 Dec 19;2025:9721061. doi: 10.1155/jdr/9721061. eCollection 2025.
- Derived from this study: PubMed 41231769Chen Q, Liu J, Madonna R, Li F, Chen S, Li L, Wu X, Maimati Y, Ding F, Wang X, Shen Y, Zhang R, Shen W, Dai Y, Lu L, De Caterina R. Vasostatin-2 attenuates injury-induced neointimal hyperplasia through the ACE2/MasR/PPARgamma/NR1D1/Gas1 axis. Cardiovasc Res. 2025 Nov 22;121(14):2260-2277. doi: 10.1093/cvr/cvaf192.
- Derived from this study: PubMed 40175898Mao LS, Geng L, Wang YX, Qi Y, Wang MH, Ding FH, Dai Y, Lu L, Zhang Q, Shen WF, Shen Y. Clinical risk score to predict poor coronary collateralization in type 2 diabetic patients with chronic total occlusion. BMC Cardiovasc Disord. 2025 Apr 2;25(1):250. doi: 10.1186/s12872-025-04687-8.
- Individual participant dataSharing planned: No
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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.
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 Chronic Total Occlusion of Coronary Artery and Diabetes Mellitus, Type 2, run by Ruijin 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?
The sponsor lists 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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 Ying Shen, PhD (18601683266, rjshenying@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac function evaluated by echocardiography (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06054126, which also lists 3 linked publications.
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 23 Oct 2023.