Investigating coronary collateral circulation in diabetic patients with blocked arteries
The Development of Coronary Collateralization in Type 2 Diabetic Patients With Chronic Total Occlusion
This study looks at how having blocked arteries affects the heart's backup blood flow in people with Type 2 diabetes to see if it helps their heart health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06054126 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding the factors that influence the development of coronary collateral circulation in patients with Type 2 diabetes who have chronic total occlusion of coronary arteries. It involves enrolling consecutive patients with at least one total occlusion, grading their collateral circulation using the Rentrop method, and analyzing their clinical and laboratory characteristics at hospital admission. Additionally, the study will evaluate cardiac function through echocardiography one year after enrollment to assess the impact of collateral circulation on heart health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-90 with Type 2 diabetes and at least one coronary artery lesion that is totally occluded.
Not a fit: Patients with severe kidney impairment, advanced heart failure, or recent coronary interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of coronary artery disease in diabetic patients, potentially enhancing their cardiac health.
How similar studies have performed: While studies on coronary collateral circulation exist, this specific focus on Type 2 diabetic patients with chronic total occlusion is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Ying Shen, PhD
- Email: rjshenying@qq.com
- Phone: 18601683266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.