Toe-brachial Index and Coronary Calcification in Type 1 and 2 Diabetes (ACCoDiab)
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|ClinicalTrials.gov Identifier: NCT03920683|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : September 10, 2019
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
|Condition or disease||Intervention/treatment|
|Coronary Artery Calcification||Other: Data collection|
|Study Type :||Observational|
|Estimated Enrollment :||650 participants|
|Official Title:||Association Between Toe-brachial Index and Coronary Calcification in Asymptomatic Patients With Type 1 and Type 2 Diabetes Mellitus|
|Actual Study Start Date :||July 8, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
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
Retrospective : data from medical record Prospective : vital statuts from follow-up phone call
- Toe-brachial index [ Time Frame: During the one-day hospitalization in the diabetes department ]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.
- Vital statuts [ Time Frame: Through study completion, an average of 8 months. ]Vital statuts will be collected by the investigator during a follow-up phone call.
- Coronary artery calcification [ Time Frame: Through study completion, an average of 8 months. ]Coronary artery calcification score has been measured using a cardiac-gated multidetector computerized tomography (semi-automated software using the calcium score developed by Agatston. It is defined as a lesion with a density above 130 Hounsfield units, and with an area above 1mm². Coronary artery calcification score was the amount of the score of left main artery, left anterior descending artery, left circumflex artery and right coronary artery. Standardized categories are used to describe coronary artery calcification score : 0 for absence of calcified plaque, 1 to 10 for minimal plaque, 11 to 100 for mild plaque, 101 to 400 for moderate plaque, and >400 for severe plaque. Age, sex and race-specific percentiles of coronary artery calcification score are also performed, using the methodology described in the Multi-Ethnic Study of Atherosclerosis (validated only for patients between 45 and 84 years old). A score ≥75th percentile defines a high cardiovascular risk.
- Stress myocardial perfusion tomography [ Time Frame: Through study completion, an average of 8 months. ]Stress myocardial perfusion tomography was realized using a cycloergometer until maximal heart rate (stopped in case of clinical symptoms or ECG abnormalities). Abnormal stress myocardial perfusion tomography is defined by a perfusion defect on stress images on at least one of the 17 anatomical region of the left ventricle, and absent on rest images.
- Coronary angiography [ Time Frame: Through study completion, an average of 8 months. ]Coronary angiography has been performed in the cardiology department, in Pitié-Salpêtrière hospital. A coronary stenosis is defined by a stenosis≥ 50%.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920683
|Contact: Olivier BOURRON, MD, PhD||0142178118 ext +firstname.lastname@example.org|
|Contact: Anne-Caroline JEANNIN||0142178118 ext +email@example.com|
|Diabetology department, Pitié-Salpêtrière hospital||Recruiting|
|Paris, France, 75013|
|Contact: Olivier BOURRON, MD, PhD 0142178118 ext +33 firstname.lastname@example.org|
|Contact: Anne-Caroline JEANNIN 0142178118 ext +33|
|Principal Investigator:||Olivier BOURRON, MD, PhD||Assistance Publique Hoptiaux de Paris|