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

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06054126

Collaborator

(none)

2,000

Enrollment

Location

193.9

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Total Occlusion of Coronary Artery Diabetes Mellitus, Type 2	Other: Echocardiography

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. We 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

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Echocardiography 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.	Other: Echocardiography Cardiac function was evaluated by echocardiography at one year follow-up.

Arm

Intervention/Treatment

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.

Other: Echocardiography

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.

Other: Echocardiography

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

Outcome Measures

Primary Outcome Measures

Cardiac function [12 months]
Assessed by echocardiography

Secondary Outcome Measures

Cardiovascular events [up to 5 years]
The incidence of MACCE (major adverse cardiac and cerebrovascular events)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ruijin Hospital

ClinicalTrials.gov Identifier:

NCT06054126

Other Study ID Numbers:

sy11218

First Posted:

Sep 26, 2023

Last Update Posted:

Sep 26, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ruijin Hospital

Atherosclerosis

Diabetes Mellitus, Type 2

Chronic Total Occlusion of Coronary Artery

Coronary artery disease

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 26, 2023