Diabetes Clinical Trial
— FINDOfficial title:
Functional and Anatomic Imaging Versus No Testing in Asymptomatic High-risk Diabetic Patients
The aim of our study was to evaluate 1- and 3-year outcome of alternative imaging strategies in asymptomatic high-risk diabetic patients: functional stress echocardiography combined with coronary flow reserve (CFR) and strain imaging, or computed tomography (CT) angiography with direct visualization of coronary arteries, and no testing at all.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility | Inclusion Criteria: Asymptomatic patients (>30 years) with duration of diabetes =10 years without target organ damage plus any other additional risk factor including age, hypertension, dyslipidemia, smoking, and obesity. Exclusion Criteria: - Patient categorized as very high or moderate risk for CV diseases - Any symptoms suggestive of angina or heart failure - Patients with baseline ECG or echo abnormalities - Patients with known CV disease, or previous myocardial revascularization - Patients with target organ damage defined as proteinuria, renal impairment defined as eGFR <30 mL/min/1.73 m2, left ventricular hypertrophy, or retinopathy |
Country | Name | City | State |
---|---|---|---|
Serbia | Clinical Centre of Serbia | Belgrade |
Lead Sponsor | Collaborator |
---|---|
Clinical Centre of Serbia |
Serbia,
Authors/Task Force Members, Rydén L, Grant PJ, Anker SD, Berne C, Cosentino F, Danchin N, Deaton C, Escaned J, Hammes HP, Huikuri H, Marre M, Marx N, Mellbin L, Ostergren J, Patrono C, Seferovic P, Uva MS, Taskinen MR, Tendera M, Tuomilehto J, Valensi P, — View Citation
Clerc OF, Fuchs TA, Stehli J, Benz DC, Gräni C, Messerli M, Giannopoulos AA, Buechel RR, Lüscher TF, Pazhenkottil AP, Kaufmann PA, Gaemperli O. Non-invasive screening for coronary artery disease in asymptomatic diabetic patients: a systematic review and m — View Citation
Cosentino F, Grant PJ, Aboyans V, Bailey CJ, Ceriello A, Delgado V, Federici M, Filippatos G, Grobbee DE, Hansen TB, Huikuri HV, Johansson I, Jüni P, Lettino M, Marx N, Mellbin LG, Östgren CJ, Rocca B, Roffi M, Sattar N, Seferovic PM, Sousa-Uva M, Valensi — View Citation
Emerging Risk Factors Collaboration, Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes melli — View Citation
Galsgaard J, Persson F, Hansen TW, Jorsal A, Tarnow L, Parving HH, Rossing P. Plasma high-sensitivity troponin T predicts end-stage renal disease and cardiovascular and all-cause mortality in patients with type 1 diabetes and diabetic nephropathy. Kidney — View Citation
Huelsmann M, Neuhold S, Strunk G, Moertl D, Berger R, Prager R, Abrahamian H, Riedl M, Pacher R, Luger A, Clodi M. NT-proBNP has a high negative predictive value to rule-out short-term cardiovascular events in patients with diabetes mellitus. Eur Heart J. — View Citation
Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimig — View Citation
Lièvre MM, Moulin P, Thivolet C, Rodier M, Rigalleau V, Penfornis A, Pradignac A, Ovize M; DYNAMIT investigators. Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the — View Citation
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der — View Citation
Price AH, Weir CJ, Welsh P, McLachlan S, Strachan MWJ, Sattar N, Price JF. Comparison of non-traditional biomarkers, and combinations of biomarkers, for vascular risk prediction in people with type 2 diabetes: The Edinburgh Type 2 Diabetes Study. Atherosc — View Citation
Valenti V, Hartaigh BÓ, Cho I, Schulman-Marcus J, Gransar H, Heo R, Truong QA, Shaw LJ, Knapper J, Kelkar AA, Sciarretta S, Chang HJ, Callister TQ, Min JK. Absence of Coronary Artery Calcium Identifies Asymptomatic Diabetic Individuals at Low Near-Term Bu — View Citation
Wackers FJ, Young LH, Inzucchi SE, Chyun DA, Davey JA, Barrett EJ, Taillefer R, Wittlin SD, Heller GV, Filipchuk N, Engel S, Ratner RE, Iskandrian AE; Detection of Ischemia in Asymptomatic Diabetics Investigators. Detection of silent myocardial ischemia i — View Citation
Young LH, Wackers FJ, Chyun DA, Davey JA, Barrett EJ, Taillefer R, Heller GV, Iskandrian AE, Wittlin SD, Filipchuk N, Ratner RE, Inzucchi SE; DIAD Investigators. Cardiac outcomes after screening for asymptomatic coronary artery disease in patients with ty — View Citation
Zellweger MJ, Maraun M, Osterhues HH, Keller U, Müller-Brand J, Jeger R, Pfister O, Burkard T, Eckstein F, von Felten S, Osswald S, Pfisterer M. Progression to overt or silent CAD in asymptomatic patients with diabetes mellitus at high coronary risk: main — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiovascular events (MACE) | Number of participants with all-cause mortality, non-fatal MI and unstable angina | 1 to 3 years | |
Secondary | Individual MACE | Number of participants with all-cause mortality, cardiovascular mortality, non-fatal MI, revascularization (PCI or CABG), acute coronary syndrome, appearance and/or hospitalization for angina, and stroke | 1 to 3 years | |
Secondary | Testing-driven invasive angiography and revascularization | Number of participants undergoing invasive coronary angiography (ICA) and revascularization and rate of MACE due to invasive angiogaphy and revascularization | 1 to 3 years | |
Secondary | Prognostic role of iFR/FFR imaging in patients referred to angiography | Number of participants with MACE and rate of MACE in patients undergoing instantaneous wave-free ratio (iFR) and fractional flow reserve in (FFR) | 1 to 3 years | |
Secondary | Safety and outcome of revascularization in testing arms | Number of participants with MACE and rate of MACE due to revascularization | 1 to 3 years | |
Secondary | The role of biomarkers in high risk DM patients on their outcome (MACE) | Value of C-reactive protein (CRP), NT-pro BNP, and hsTnT in all participants | 1 to 3 years | |
Secondary | The impact of antidiabetic therapy and sugar control in high risk DM patients on their outcome | Number of participants with MACE and rate of MACE in high risk DM participants regarding antidiabetic therapy | 1 to 3 years | |
Secondary | Differences in the outcome between functional and angiographic imaging in imaging arm | Number of participants with MACE and rate of MACE regarding the initial imaging modality | 1 to 3 years |
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