COronary CoLLateralization in Type 2 diabEtic Patients With Chronic Total Occlusion

NCT ID: NCT06054126

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2026-03-01

Brief Summary

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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

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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.

Conditions

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Chronic Total Occlusion of Coronary Artery Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Echocardiography

Intervention Type OTHER

Cardiac function was evaluated by echocardiography at one year follow-up.

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.

Echocardiography

Intervention Type OTHER

Cardiac function was evaluated by echocardiography at one year follow-up.

Interventions

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Echocardiography

Cardiac function was evaluated by echocardiography at one year follow-up.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Shen, PhD

Role: CONTACT

18601683266

Linshuang Mao

Role: CONTACT

13736051345

Facility Contacts

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Ying Shen

Role: primary

18601683266

References

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Mao 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.

Reference Type DERIVED
PMID: 40175898 (View on PubMed)

Other Identifiers

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sy11218

Identifier Type: -

Identifier Source: org_study_id

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