COronary CoLLateralization in Type 2 diabEtic Patients With Chronic Total Occlusion

Study Overview
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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.

Official Title
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The Development of Coronary Collateralization in Type 2 Diabetic Patients With Chronic Total Occlusion

Conditions
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Chronic Total Occlusion of Coronary Artery, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Echocardiography


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM with good CCC<br>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. | Other: Echocardiography<br>* Cardiac function was evaluated by echocardiography at one year follow-up.<br>|
| T2DM with poor CCC<br>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. | Other: Echocardiography<br>* Cardiac function was evaluated by echocardiography at one year follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac function evaluated by echocardiography | Assessed by echocardiography | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events | The incidence of MACCE (major adverse cardiac and cerebrovascular events) | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Diabetes Mellitus, Type 2, Chronic Total Occlusion of Coronary Artery, Coronary artery disease