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 |
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Coronary Artery Calcification | Other: Data collection |
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 |
Actual Primary Completion Date : | July 8, 2019 |
Estimated Study Completion Date : | July 8, 2021 |
Group/Cohort | Intervention/treatment |
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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.
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Other: Data collection
Retrospective : data from medical record Prospective : vital statuts from follow-up phone call
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Olivier BOURRON, MD, PhD | 0142178118 ext +33 | olivier.bourron@aphp.fr | |
Contact: Anne-Caroline JEANNIN | 0142178118 ext +33 | anneca5@hotmail.com |
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 |
Principal Investigator: | Olivier BOURRON, MD, PhD | Assistance Publique Hoptiaux de Paris |
Tracking Information | |||||||||
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First Submitted Date | January 25, 2019 | ||||||||
First Posted Date | April 19, 2019 | ||||||||
Last Update Posted Date | February 25, 2021 | ||||||||
Actual Study Start Date | July 8, 2019 | ||||||||
Actual Primary Completion Date | July 8, 2019 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Toe-brachial Index and Coronary Calcification in Type 1 and 2 Diabetes | ||||||||
Official Title | Association Between Toe-brachial Index and Coronary Calcification in Asymptomatic Patients With Type 1 and Type 2 Diabetes Mellitus | ||||||||
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 |
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Detailed Description |
Cardiovascular disease is the most common cause of death in diabetes. Actually, systematic screening of asymptomatic diabetic patients for silent myocardial ischemia is highly controversial, and is recommended for selected high-risk patients. Calcium artery calcification score predicts major coronary events, and improves risk reclassification in asymptomatic diabetic patients. The guidelines of the european society of cardiology published in 2013 recommend a screening for silent myocardial ischemia in patients with a high coronary score, without defining a cut-off value. But, assessing cardiovascular risk with calcium coronary score in all asymptomatic patients with diabetes is not feasible. In fact, calcium coronary score expose patients to radiation, is expensive, and is not easily available in health centres. It cannot be used to screen the 4 millions of diabetic patients in France. It could be interesting to identify the predictive factors of a high calcium coronary score, in order to perform coronary artery calcification score only in selected high-risk patients. Ankle-brachial index is also a marker of cardiovascular risk. Several prospective studies revealed that a low ankle-brachial index predicts cardiovascular events and mortality, and all-cause mortality in diabetes. Nevertheless, a study involving 1343 patients with type 2 diabetes from MESA and Heinz Nixdorf Recall studies has showed that coronary artery calcification score provides better risk reclassification than ankle-brachial index. Toe-brachial index is particularly relevant in diabetes for peripheral arterial disease screening. 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 and 2 diabetes. The hypothesis is that toe-brachial index is associated with a high coronary artery calcification score. It could be performed first to identify patients who require a coronary artery calcification score. The measurement of toe-brachial index is fully automated, is reliable and reproducible and is cost-effectiveness. This technique is suitable for large-scale screening. Secondary objectives are :
This is a cross-sectional and single-centre study, with retrospective data collection. All 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 in Paris, are eligible. Data are collected in patients' medical records. Clinical, biological and imaging data were collected previously during their one-day hospitalization. Clinical data are age, sex, diabetes duration, type of diabetes, high blood pressure, dyslipidemia, smoking status, diabetes comorbidities and current medication. Physical examination data are weight, height, body mass index, blood pressure, orthostatic hypotension, symptoms of diabetic peripheral neuropathy, monofilament test, VibraTip and peripheral pulses. Biological data are HbA1c, fasting blood glucose, HDL-cholesterol, LDL-cholesterol calculated using Friedewald equation, total cholesterol, triglycerides, estimated glomerular filtration rate (eGFR) by modification of diet in renal disease (MDRD), urinary albumin/creatinine ratio, ASAT, ALAT, fibromax protein C reactive and ferritin. Blood and urinary samples have been collected during the one-day hospitalization, and have been analyzed in biochemical department, in Pitié-Salpêtrière hospital. A retinography bas been performed in patient with known retinopathy or with a mild nonproliferative retinopathy, without ophthalmologic examination since 1 year. Severe retinopathy is defined by severe nonproliferative retinopathy or proliferative retinopathy or retinopathy treated with laser. Diabetic nephropathy is known or is defined by a urinary albumin/creatinine ratio up to 3 mg/mmol associated with a diabetic retinopathy or a peripheral neuropathy. Albuminuria stages are defined by the urinary albumin/creatinine ratio : no albuminuria if ratio is <3mg/mmol, microalbuminuria if ratio is ≥3 mg/mmol and <30mg/mmol and macroalbuminuria if ratio is ≥30 mg/mmol. Diabetic peripheral neuropathy is known or is defined by typical symptoms or abnormal monofilament test or abnormal ViBratip. Autonomic neuropathy is defined by gastroparesis, cardiovascular autonomic neuropathy, orthostatic hypotension, urinary autonomic dysfunction neuropathy and Charcot foot. Peripheral artery disease is known or is defined by a toe-brachial index <0.7 associated with 2 abnormal pulses on the same side or by a leg artery stenosis ≥ 70% on the ultrasound examination. Carotid arteries have been studied using an echo-doppler. Intima-media thickness has been measured on longitudinal images, over a 1 cm plaque-free segment free of plaque, 1 cm proximal to the carotid artery bifurcation. Two measurement methods have been used to evaluate intima-media thickness: an automated method using a 3 to 8 MHz linear array transducer (Philips IE33, Koninklijke Philips N.V., Netherlands) and Philips Q-Lab version 8 software (Koninklijke Philips N.V., Netherlands), and a manual method using a 8 or a 4 to 9 MHz transducer (Acuson Sequoi ou Siemens Acuson, respectively). Endpoints are the highest intima-media thickness value between right and left side, and the mean intima-media thickness from right and left side. Plaque is defined as a stenosis <50%, using NASCET and ECST criteria. Carotid stenosis is defined by a stenosis ≥ 50%, using NASCET and ECST criteria. Toe-brachial index measurement is described in "primary outcome measures". Coronary artery calcification score, stress myocardial perfusion tomography and coronary angiography are described in "secondary outcome measures". Stress myocardial perfusion tomography has been performed if coronary artery calcification score was >100. Coronary angiography has been performed if stress myocardial perfusion tomography was abnormal. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Other |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
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. | ||||||||
Condition | Coronary Artery Calcification | ||||||||
Intervention | Other: Data collection
Retrospective : data from medical record Prospective : vital statuts from follow-up phone call
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Study Groups/Cohorts | 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.
Intervention: Other: Data collection
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
650 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | July 8, 2021 | ||||||||
Actual Primary Completion Date | July 8, 2019 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03920683 | ||||||||
Other Study ID Numbers | APHP180409 2018-A02748-47 ( Other Identifier: ANSM ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||||||
Study Sponsor | Assistance Publique - Hôpitaux de Paris | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Assistance Publique - Hôpitaux de Paris | ||||||||
Verification Date | February 2021 |