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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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


Condition or disease Intervention/treatment
Coronary Artery Calcification Other: Data collection

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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%.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920683


Contacts
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Contact: Olivier BOURRON, MD, PhD 0142178118 ext +33 olivier.bourron@aphp.fr
Contact: Anne-Caroline JEANNIN 0142178118 ext +33 anneca5@hotmail.com

Locations
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France
Diabetology department, Pitié-Salpêtrière hospital Recruiting
Paris, France, 75013
Contact: Olivier BOURRON, MD, PhD    0142178118 ext +33    olivier.bourron@aphp.fr   
Contact: Anne-Caroline JEANNIN    0142178118 ext +33      
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Olivier BOURRON, MD, PhD Assistance Publique Hoptiaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03920683     History of Changes
Other Study ID Numbers: APHP180409
2018-A02748-47 ( Other Identifier: ANSM )
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prediction of coronary artery calcification score
Diabetes mellitus
Toe-brachial index
Additional relevant MeSH terms:
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Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases