Toe-brachial Index and Coronary Calcification in Type 1 and 2 Diabetes

NCT03920683 | Completed

• 2 other identifiers: APHP1804092018-A02748-47
• Study Type: observational
• Target: 707
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is not a coronary risk equivalent, despite cardiovascular disease is the most common cause of death in diabetes. So, to identify diabetic patients at high cardiovascular risk is necessary. Coronary artery calcification score predicts major coronary events, and improves risk reclassification in asymptomatic diabetic patients. But, cornary artery calcification score is expensive and exposes patients to radiation. So, it cannot be used for large-scale screening. It could be interesting to identify the predictive factors of coronary artery calcification score. Toe-brachial index is relevant in diabetic patients for the screening of peripheral arterial disease, and predicts cardiovascular events. The aim of this study is to evaluate the association between toe-brachial index and coronary artery calcification score in asymptomatic patients with type 1 or 2 diabetes. The hypothesis is that toe-brachial index is associated with high coronary artery calcification score. It could be performed first to identify patients who require a coronary artery calcification score. It measurement is reliable, fully automated, repoducible ans cost-effectiveness. This is a cross-sectional study, with restrospective data collection. All patients addressed to a one-day hospitalization to assess cardiovascular comorbidities are eligible. Data are collected in patients'medical records. Clinical, biological and imaging data were collected previously during their one-day hospitalization

Conditions

Coronary Artery Calcification

Keywords

Prediction of coronary artery calcification score; Diabetes mellitus; Toe-brachial index

Outcome Measures

Primary Outcomes (1)

• Toe-brachial index

  Toe-brachial index has been performed by a clinician nurse of the diabetology department, using a fully automatic photoplethysmographic device, Systoe®. Three measurements have been performed on the first toe of both foot : the first one to permit blood volumeflow, and the mean of the others has been recorded to define toe blood pressure. Toe-brachial index is the ratio of toe systolic blood pressure and brachial systolic blood pressure. The lowest value of toe-brachial index between the right and the left side is used. Toe-brachial index cut-off is 0.7.

  During the one-day hospitalization in the diabetes department

Secondary Outcomes (4)

• Vital statuts

  Through study completion, an average of 8 months.

• Coronary artery calcification

  Through study completion, an average of 8 months.

• Stress myocardial perfusion tomography

  Through study completion, an average of 8 months.

• Coronary angiography

  Through study completion, an average of 8 months.

Study Arms (1)

Diabete type 1 and 2

Data collection from patients treated in the diabetes department, in Pitié-Salpêtrière hospital, and adressed for a one-day hospitalization to assess cardiovascular comorbidities.

Other: Data collection

Interventions

Data collection OTHER

Retrospective : data from medical record Prospective : vital statuts from follow-up phone call

Diabete type 1 and 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated in the diabetes department, in Pitié-Salpêtrière hospital, and adressed for a one-day hospitalization to assess cardiovascular comorbidities.

You may qualify if:

• Age ≥ 18 ans
• Diabetes mellitus (type 1 or 2)
• Patients addressed to a one-day hospitalization to assess cardiovascular comorbidities, between January 2014 and May 2017, in the diabetes department, in the Pitié-Salpêtrière hospital
• Coronary artery calcium score available
• Toe-brachial index available

You may not qualify if:

• History of coronary artery disease
• History of Raynaud's syndrome
• Opposition of the patient

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Diabetology department, Pitié-Salpêtrière hospital

Paris, 75013, France

Location

Related Publications (1)

• Denimal D, Ponnaiah M, Jeannin AC, Phan F, Hartemann A, Boussouar S, Charpentier E, Redheuil A, Foufelle F, Bourron O. Non-alcoholic fatty liver disease biomarkers estimate cardiovascular risk based on coronary artery calcium score in type 2 diabetes: a cross-sectional study with two independent cohorts. Cardiovasc Diabetol. 2024 Feb 13;23(1):69. doi: 10.1186/s12933-024-02161-x.

  PMID: 38351039 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Olivier BOURRON, MD, PhD

  Assistance Publique Hoptiaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: April 19, 2019
• Study Start: July 8, 2019
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)