Clinical trial NCT06054126: COronary CoLLateralization in Type 2 diabEtic Patients With Chronic Total Occlusion
Official title: The Development of Coronary Collateralization in Type 2 Diabetic Patients With Chronic Total Occlusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Total Occlusion of Coronary Artery
Diabetes Mellitus, Type 2
Keywords: Atherosclerosis
Diabetes Mellitus, Type 2
Chronic Total Occlusion of Coronary Artery
Coronary artery disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients with chronic total occlusion undergone coronary angiography at Ruijin Hospital, Shanghai, China are consecutively enrolled.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac function evaluated by echocardiography
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular events
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: