UK CARDIOvascular Immune-Mediated Inflammatory Diseases (CARDIO-IMID) Registry Study

NCT06478277 | Recruiting

• 1 other identifier: 341045
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to develop a large, deeply characterised cohort that will be a platform for collaborative clinical and translational research into cardiovascular (CV) disease (CVD) and Immune-mediated-inflammatory-diseases (IMID). The main aim is to evaluate whether existing blood cardiac biomarkers predict adverse cardiovascular outcomes. The study will capture standard of care CV and associated health data (clinical, biochemistry/pathology and investigations) in patients across the IMIDs. Optional biological and/or imaging sub-studies will provide additional data and/or samples for associated analyses.

Conditions

Cardiovascular Diseases; Immune-Mediated Inflammatory Diseases

Keywords

Cardiovascular disease; Immune-mediated Inflammatory Diseases; Registry

Outcome Measures

Primary Outcomes (2)

• Number of participants with abnormal high-sensitivity cardiac troponin I/T levels

  The total number of participants with abnormal high-sensitivity troponin I/T levels (assessed by blood draw) will be measured. Unit: number of participants

  5 years

• Number of participants with abnormal N-terminal pro B-type natriuretic peptide (NT-pro BNP) levels

  The total number of participants with abnormal NT-pro BNP levels (assessed by blood draw) will be measured. Unit: number of participants

  5 years

Secondary Outcomes (12)

• Number of participants with atherosclerotic cardiovascular disease (ASCVD)

  5 years

• Number of participants with myopericardial involvement

  5 years

• Number of participants with other cardiovascular events

  5 years

• Atrial and ventricular volumetrics

  5 years

• Systolic and diastolic function

  5 years

Eligibility Criteria

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

Study Population

Participants will be recruited from NHS secondary care in the United Kingdom. Potential participants may be identified from clinics, wards, diagnostic pathways and departments, electronic and paper-based health records, databases and waiting lists in secondary care. All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation, except where the study inclusion and exclusion criteria explicitly state otherwise.

You may qualify if:

• Written informed consent
• Diagnosis of an IMID by a rheumatologist with categorisation into one of the following:
• i. IMID-'higher risk' CVD: individuals who have a risk of developing CVD (based on traditional risk factors and/or IMID-specific factors) but no history of CVD
• Coronary artery disease (CAD): specifically, a high pre-test probability of CAD based on clinical risk factors (e.g. QRISK3 score ≥10%) and/or elevated biochemical markers (high-sensitivity C-reactive protein ≥2mg/L and/or Lipoprotein(a) ≥70mg/dL)
• Myopericardial involvement: Specific IMID and/or cardiovascular indicators that place at increased risk e.g. autoantibody associations, presence of peripheral myositis or other major organ involvement; incidental raised serum cardiac biomarkers (troponin and/or NT-pro BNP), on routine testing
• ii. Incident (new) IMID-CVD: Patients with IMID that present with a new history of CVD
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• ASCVD i. Major adverse cardiovascular events (MACE):
• \- Non-fatal myocardial infarction.
• \- Non-fatal stroke of any classification, including reversible focal neurologic
• \- Defects with imaging evidence of a new cerebral lesion consistent with ischemia or haemorrhage.
• ii. Other cardiovascular events not accounted for in the MACE-3 composite 2)a)i:
• \- Hospitalization for unstable angina
• \- Coronary revascularization
• \- Hospitalization for heart failure

You may not qualify if:

• Age less than 18 years
• Unable to give informed consent
• Standard of care contraindications to:
• CMR: metal implant eg metal fragments in the eye, pacemaker; claustrophobia; inability to lie flat
• Magnetic Resonance Imaging (MRI) contrast: renal failure with estimated glomerular filtration rate (eGFR) \<30,

Sponsors & Collaborators

• University of Manchester: lead
• University of Cambridge: collaborator
• University of Oxford: collaborator
• Swansea University: collaborator
• University of Edinburgh: collaborator
• University of Leeds: collaborator
• Imperial College London: collaborator
• Medical Research Council: collaborator
• British Heart Foundation: collaborator
• British Heart Foundation Data Science Centre: collaborator

Study Sites (2)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

RECRUITING

Countess of Chester Hospital NHS Foundation Trust

Chester, CH2 1UL, United Kingdom

RECRUITING

Related Publications (20)

• Luscher TF. Heart failure: the cardiovascular epidemic of the 21st century. Eur Heart J. 2015 Feb 14;36(7):395-7. doi: 10.1093/eurheartj/ehv004. No abstract available.

  PMID: 25681826 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

• Chang PP, Wruck LM, Shahar E, Rossi JS, Loehr LR, Russell SD, Agarwal SK, Konety SH, Rodriguez CJ, Rosamond WD. Trends in Hospitalizations and Survival of Acute Decompensated Heart Failure in Four US Communities (2005-2014): ARIC Study Community Surveillance. Circulation. 2018 Jul 3;138(1):12-24. doi: 10.1161/CIRCULATIONAHA.117.027551. Epub 2018 Mar 8.

  PMID: 29519849 BACKGROUND

• Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.

  PMID: 16855265 BACKGROUND

• Lewis GA, Schelbert EB, Williams SG, Cunnington C, Ahmed F, McDonagh TA, Miller CA. Biological Phenotypes of Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2017 Oct 24;70(17):2186-2200. doi: 10.1016/j.jacc.2017.09.006.

  PMID: 29050567 BACKGROUND

• Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJ, Michelson EL, Olofsson B, Ostergren J; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet. 2003 Sep 6;362(9386):777-81. doi: 10.1016/S0140-6736(03)14285-7.

  PMID: 13678871 BACKGROUND

• Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.

  PMID: 19001508 BACKGROUND

• Redfield MM, Chen HH, Borlaug BA, Semigran MJ, Lee KL, Lewis G, LeWinter MM, Rouleau JL, Bull DA, Mann DL, Deswal A, Stevenson LW, Givertz MM, Ofili EO, O'Connor CM, Felker GM, Goldsmith SR, Bart BA, McNulty SE, Ibarra JC, Lin G, Oh JK, Patel MR, Kim RJ, Tracy RP, Velazquez EJ, Anstrom KJ, Hernandez AF, Mascette AM, Braunwald E; RELAX Trial. Effect of phosphodiesterase-5 inhibition on exercise capacity and clinical status in heart failure with preserved ejection fraction: a randomized clinical trial. JAMA. 2013 Mar 27;309(12):1268-77. doi: 10.1001/jama.2013.2024.

  PMID: 23478662 BACKGROUND

• Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.

  PMID: 24716680 BACKGROUND

• Redfield MM, Anstrom KJ, Levine JA, Koepp GA, Borlaug BA, Chen HH, LeWinter MM, Joseph SM, Shah SJ, Semigran MJ, Felker GM, Cole RT, Reeves GR, Tedford RJ, Tang WH, McNulty SE, Velazquez EJ, Shah MR, Braunwald E; NHLBI Heart Failure Clinical Research Network. Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2015 Dec 10;373(24):2314-24. doi: 10.1056/NEJMoa1510774. Epub 2015 Nov 8.

  PMID: 26549714 BACKGROUND

• Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.

  PMID: 31475794 BACKGROUND

• Shah SJ. Precision Medicine for Heart Failure with Preserved Ejection Fraction: An Overview. J Cardiovasc Transl Res. 2017 Jun;10(3):233-244. doi: 10.1007/s12265-017-9756-y. Epub 2017 Jun 5.

  PMID: 28585183 BACKGROUND

• Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7.

  PMID: 22064591 BACKGROUND

• Shah AM, Claggett B, Sweitzer NK, Shah SJ, Anand IS, O'Meara E, Desai AS, Heitner JF, Li G, Fang J, Rouleau J, Zile MR, Markov V, Ryabov V, Reis G, Assmann SF, McKinlay SM, Pitt B, Pfeffer MA, Solomon SD. Cardiac structure and function and prognosis in heart failure with preserved ejection fraction: findings from the echocardiographic study of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) Trial. Circ Heart Fail. 2014 Sep;7(5):740-51. doi: 10.1161/CIRCHEARTFAILURE.114.001583. Epub 2014 Aug 13.

  PMID: 25122186 BACKGROUND

• Cohen JB, Schrauben SJ, Zhao L, Basso MD, Cvijic ME, Li Z, Yarde M, Wang Z, Bhattacharya PT, Chirinos DA, Prenner S, Zamani P, Seiffert DA, Car BD, Gordon DA, Margulies K, Cappola T, Chirinos JA. Clinical Phenogroups in Heart Failure With Preserved Ejection Fraction: Detailed Phenotypes, Prognosis, and Response to Spironolactone. JACC Heart Fail. 2020 Mar;8(3):172-184. doi: 10.1016/j.jchf.2019.09.009. Epub 2020 Jan 8.

  PMID: 31926856 BACKGROUND

• Segar MW, Patel KV, Ayers C, Basit M, Tang WHW, Willett D, Berry J, Grodin JL, Pandey A. Phenomapping of patients with heart failure with preserved ejection fraction using machine learning-based unsupervised cluster analysis. Eur J Heart Fail. 2020 Jan;22(1):148-158. doi: 10.1002/ejhf.1621. Epub 2019 Oct 21.

  PMID: 31637815 BACKGROUND

• Kao DP, Lewsey JD, Anand IS, Massie BM, Zile MR, Carson PE, McKelvie RS, Komajda M, McMurray JJ, Lindenfeld J. Characterization of subgroups of heart failure patients with preserved ejection fraction with possible implications for prognosis and treatment response. Eur J Heart Fail. 2015 Sep;17(9):925-35. doi: 10.1002/ejhf.327. Epub 2015 Aug 6.

  PMID: 26250359 BACKGROUND

• Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.

  PMID: 25398313 BACKGROUND

• Ahmad T, Desai NR, Januzzi JL. Heart Failure With Preserved Ejection Fraction: Many Emperors With Many Clothes. JACC Heart Fail. 2020 Mar;8(3):185-187. doi: 10.1016/j.jchf.2019.11.004. Epub 2020 Jan 8. No abstract available.

  PMID: 31926855 BACKGROUND

• Porrello ER, Delbridge LMD. HFpEF-Time to Explore the Role of Genetic Heterogeneity in Phenotypic Variability: New Mechanistic Insights Offer Promise for Personalized Therapies. Circulation. 2019 Nov 12;140(20):1607-1609. doi: 10.1161/CIRCULATIONAHA.119.042496. Epub 2019 Nov 11. No abstract available.

  PMID: 31710521 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling will be performed that may support deoxyribonucleic acid (DNA) extraction, plasma and serum. The total volume of blood collected will be up to maximum 75 ml. Multiple types of analyses may be performed on the donated samples, including genomics; transcriptome analysis; protein, lipid, carbohydrate, biochemistry, metabolomics and other analytes. As technology is continually advancing it is not possible to comprehensively list analysis methods that may be applied to samples in the future, but UK CARDIO-IMID will provide a powerful resource for evaluating emerging methodologies and analyses.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Maya H Buch, MD

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia Reeves

CONTACT

+44 161 306 5600; georgia.reeves@manchester.ac.uk

James Lawrence

CONTACT

+44 161 306 5600; james.lawrence@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology and Director of Experimental Medicine at the Centre for Musculoskeletal Research, University of Manchester

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 27, 2024
• Study Start: February 4, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

GB (2)