NCT06054126

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

October 23, 2023

Status Verified

August 1, 2023

Enrollment Period

16 years

First QC Date

September 19, 2023

Last Update Submit

October 18, 2023

Conditions

Keywords

AtherosclerosisDiabetes Mellitus, Type 2Chronic Total Occlusion of Coronary ArteryCoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Cardiac function evaluated by echocardiography

    Assessed by echocardiography

    12 months

Secondary Outcomes (1)

  • Cardiovascular events

    up to 5 years

Study Arms (2)

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

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

Interventions

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

T2DM with good CCCT2DM with poor CCC

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetic patients with chronic total occlusion undergone coronary angiography at Ruijin Hospital, Shanghai, China are consecutively enrolled.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (2)

  • Mao LS, Wang YX, Qi Y, Yue ZR, Ding FH, Wang XQ, Lu L, Shen WF, Shen Y. Elevated Uric Acid/Albumin Ratio Predicts Poor Coronary Collateral Circulation in Type 2 Diabetic Patients With Stable Coronary Artery Disease. J Diabetes Res. 2025 Dec 19;2025:9721061. doi: 10.1155/jdr/9721061. eCollection 2025.

  • Mao LS, Geng L, Wang YX, Qi Y, Wang MH, Ding FH, Dai Y, Lu L, Zhang Q, Shen WF, Shen Y. Clinical risk score to predict poor coronary collateralization in type 2 diabetic patients with chronic total occlusion. BMC Cardiovasc Disord. 2025 Apr 2;25(1):250. doi: 10.1186/s12872-025-04687-8.

Biospecimen

Retention: SAMPLES WITH DNA

plasma and PBMCs

MeSH Terms

Conditions

Diabetes Mellitus, Type 2AtherosclerosisCoronary Artery Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart Diseases

Central Study Contacts

Ying Shen, PhD

CONTACT

Linshuang Mao

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

January 1, 2010

Primary Completion

December 31, 2025

Study Completion

March 1, 2026

Last Updated

October 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations