COronary CoLLateralization in Type 2 diabEtic Patients With Chronic Total Occlusion (COLLECT)

Shanghai Jiao Tong University

Status: Enrolling

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

Treatments: Other: Echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT06054126

sy11218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

T2DM with good CCC

Description:

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.

Treatment:

Other: Echocardiography

T2DM with poor CCC

Description:

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.

Treatment:

Other: Echocardiography