COronary CoLLateralization in Type 2 diabEtic Patients With Chronic Total Occlusion

Diabetes Mellitus, Type 2 Clinical Trial

— COLLECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054126
• Other study ID #: sy11218
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: March 1, 2026

Study information

• Verified date: August 2023
• Source: Ruijin Hospital
• Contact: Ying Shen, PhD
• Phone: 18601683266
• Email: rjshenying[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This retrospective cohort enrolls consecutive T2DM patients who had at least one lesion with coronary angiographic total occlusion.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Echocardiography
Cardiac function was evaluated by echocardiography at one year follow-up.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function evaluated by echocardiography	Assessed by echocardiography	12 months
Secondary	Cardiovascular events	The incidence of MACCE (major adverse cardiac and cerebrovascular events)	up to 5 years