Platelet Reactivity, B-amyloid, MOTS-c and Mortality of Type II Diabetics With CAD

NCT04027712 | Unknown DMC

• 1 other identifier: LTA_MOTS-c_bamyloid_DM_CAD
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Increased circulating b-amyloid and decreased Mitochondrial-derived peptide (MOTS-c), a peptide improving tissue insulin sensitivity, are reported in diabetes. The investigators plan to investigate the association of both biofactors with high on-clopidogrel platelet reactivity and cardiovascular mortality in type 2 diabetic patients with Coronary artery disease

Conditions

Diabetes; Clopidogrel Resistance; Amyloid; Insulin Resistance

Outcome Measures

Primary Outcomes (3)

• mots-c predicts cardiovascular mortality in diabetic with coronary artery disease

  mots-c concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality

  2 year follow up

• b amyloid predicts cardiovascular mortality in diabetic with coronary artery disease

  b amyloid concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality

  2 year follow up

• b amyloid predicts cardiovascular mortality in diabetic with coronary artery

  Resistance to clopidogrel as defined by Light Transmission Aggregometry in diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality.

  2 year follow up

Eligibility Criteria

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

Study Population

type 2 diabetic patients with coronary artery disease, documented by coronary angiography, both per os or/and parenteric antidiabetic medications and double antiplatelet therapy (DAPT), constituted by a daily dose of 100 mg acetylsalicylic acid per os and a daily dose of 75 mg clopidogrel per os should be prescribed to the patients for at least one month before inclusion in the stud

You may qualify if:

• type 2 diabetic patients with coronary artery disease, documented by coronary angiography,

You may not qualify if:

• abnormal renal function (creatinine\> 2.5 mg / dl),
• hepatic failure (bilirubin\> 2 mg / dl),
• active malignancy,
• patients treated with drugs that affect platelet function, besides aspirin 100 mg qd and clopidogrel 75 mg qd,
• patients with a history of hemorrhagic mood,
• patients with thrombocytopenia (PLTs \< 100x109 / L) and
• anemia (HCT \<28%).

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

General & University Hospital "Attikon"

Chaïdári, Attica, 12462, Greece

Location

Related Publications (1)

• Ikonomidis I, Katogiannis K, Kyriakou E, Taichert M, Katsimaglis G, Tsoumani M, Andreadou I, Maratou E, Lambadiari V, Kousathana F, Papadopoulou A, Varlamos C, Plotas P, Parissis J, Stamatelopoulos K, Alexopoulos D, Dimitriadis G, Tsantes AE. beta-Amyloid and mitochondrial-derived peptide-c are additive predictors of adverse outcome to high-on-treatment platelet reactivity in type 2 diabetics with revascularized coronary artery disease. J Thromb Thrombolysis. 2020 Apr;49(3):365-376. doi: 10.1007/s11239-020-02060-4.

  PMID: 32052315 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

fresh plasma, frozen plasma

MeSH Terms

Conditions

Diabetes Mellitus; Alzheimer Disease; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Hyperinsulinism

Study Officials

• Ignatios Ikonomidis, AssProfessor

  University of Athens

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ignatios Ikonomidis,MD,PhD,FESC, Associate Professor of Cardiology, Director of Echocardiography and the Laboratory of Preventive Cardiology, 2nd Cardiology Department, National and Kapodistrian University of Athens

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: January 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2021
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)