Imaging vs. no Testing in Asymptomatic High-risk Diabetic Patients

NCT04388280 | Unknown

• 1 other identifier: 485/20
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asymptomatic; High Risk; Diabetes

Keywords

Imaging; MACE; High risk; Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

  Number of participants with all-cause mortality, non-fatal MI and unstable angina

  1 to 3 years

Secondary Outcomes (7)

• Individual MACE

  1 to 3 years

• Testing-driven invasive angiography and revascularization

  1 to 3 years

• Prognostic role of iFR/FFR imaging in patients referred to angiography

  1 to 3 years

• Safety and outcome of revascularization in testing arms

  1 to 3 years

• The role of biomarkers in high risk DM patients on their outcome (MACE)

  1 to 3 years

Study Arms (2)

Imaging

OTHER

Echocardiography combined with coronary flow reserve (CFR) and strain imaging, or computed tomography (CT) angiography with direct visualization of coronary arteries.

Diagnostic Test: Echocardiography; Diagnostic Test: CT angiography

Observation

NO INTERVENTION

No imaging for the estimation of coronary artery disease

Interventions

Echocardiography DIAGNOSTIC_TEST

Functional assessment of coronary artery disease

Also known as: Coronary flow reserve (CFR), Wall motion abnormalities (WMA), Strain

Imaging

CT angiography DIAGNOSTIC_TEST

Anatomical assessment of coronary artery disease

Imaging

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Centre of Serbia: lead

Study Sites (1)

Clinical Centre of Serbia

Belgrade, 11000, Serbia

RECRUITING

Related Publications (14)

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• Valenti V, Hartaigh BO, 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 But Not Long-Term Risk of Mortality: A 15-Year Follow-Up Study of 9715 Patients. Circ Cardiovasc Imaging. 2016 Feb;9(2):e003528. doi: 10.1161/CIRCIMAGING.115.003528.

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  PMID: 25240454 RESULT

• Lievre 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 effectiveness of systematic screening. Trials. 2011 Jan 26;12:23. doi: 10.1186/1745-6215-12-23.

  PMID: 21269454 RESULT

• 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 type 2 diabetes: the DIAD study: a randomized controlled trial. JAMA. 2009 Apr 15;301(15):1547-55. doi: 10.1001/jama.2009.476.

  PMID: 19366774 RESULT

• Clerc OF, Fuchs TA, Stehli J, Benz DC, Grani C, Messerli M, Giannopoulos AA, Buechel RR, Luscher TF, Pazhenkottil AP, Kaufmann PA, Gaemperli O. Non-invasive screening for coronary artery disease in asymptomatic diabetic patients: a systematic review and meta-analysis of randomised controlled trials. Eur Heart J Cardiovasc Imaging. 2018 Aug 1;19(8):838-846. doi: 10.1093/ehjci/jey014.

  PMID: 29452348 RESULT

• Authors/Task Force Members; Ryden 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, Zamorano JL; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; De Backer G, Sirnes PA, Ezquerra EA, Avogaro A, Badimon L, Baranova E, Baumgartner H, Betteridge J, Ceriello A, Fagard R, Funck-Brentano C, Gulba DC, Hasdai D, Hoes AW, Kjekshus JK, Knuuti J, Kolh P, Lev E, Mueller C, Neyses L, Nilsson PM, Perk J, Ponikowski P, Reiner Z, Sattar N, Schachinger V, Scheen A, Schirmer H, Stromberg A, Sudzhaeva S, Tamargo JL, Viigimaa M, Vlachopoulos C, Xuereb RG. ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J. 2013 Oct;34(39):3035-87. doi: 10.1093/eurheartj/eht108. Epub 2013 Aug 30. No abstract available.

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• 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. Atherosclerosis. 2017 Sep;264:67-73. doi: 10.1016/j.atherosclerosis.2017.07.009. Epub 2017 Jul 12.

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• 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. 2008 Sep;29(18):2259-64. doi: 10.1093/eurheartj/ehn334. Epub 2008 Jul 23.

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Related Links

• Chow S, Shao J, Wand H. Sample size calculations in clinical research. 2nd edition. 2008.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Echocardiography; Global Longitudinal Strain; Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Branko Beleslin, MD, PhD

  Clinical Centre of Serbia

  PRINCIPAL INVESTIGATOR

• Nebojsa Lalic, MD, PhD

  Clinical Centre of Serbia

  PRINCIPAL INVESTIGATOR

• Milos Zarkovic, MD, PhD

  Clinical Centre of Serbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Branko Beleslin, MD, PhD

CONTACT

+381638328690; branko.beleslin@gmail.com

Nikola Boskovic, MD

CONTACT

+381642708940; belkan87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research

Model Details: multi-center prospective, randomized, open label, parallel group comparison of 2 diagnostic strategies

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: January 28, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)