Reliability of Cardiac Troponins for the Diagnosis of Myocardial Infarction in the Presence of Skeletal Muscle Disease

NCT03660969 | Active Not Recruiting

• 2 other identifiers: BASEL XIIResearch Grant
• Study Type: observational
• Target: 797
• Locations: 2 countries
• Sites: 5

Brief Summary

Visits to the emergency department (ED) for chest pain are extremely common and require a safe, rapid and efficacious treatment algorithm to exclude a possible AMI. These diagnostic algorithms are partly based on an important laboratory value, which showed growing utility in the diagnostic and prognostic of many cardiovascular diseases in the last years : cardiac troponin. However, some patients with muscle disease often present with unexplained elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in the absence of cardiac disease. The investigators aim at the characterization of the behaviour of this biomarker and its alternative (high-sensitive cardiac Troponin I), which will have important clinical implications on patients management.

Conditions

Myopathy; Muscle Weakness; Muscle Damage; Muscle Spasticity; Muscle Cramp; Muscle Injury; Muscle Soreness; Muscle Atrophy

Keywords

troponin

Outcome Measures

Primary Outcomes (1)

• Comparison of cTnT and cTnI levels as measured by different hs-cTn assays in patients with skeletal muscle disease.

  1 year

Secondary Outcomes (5)

• Comparison of levels of cTnT and cTnI as measured by hs-assays in matched patients with and without skeletal muscle disease.

  1 year

• Regression model of diverse patients' characteristics on levels of hs-cTnI and hs-cTnT in the context of skeletal muscle disease versus no skeletal muscle disease.

  1 year

• Prognostic value of hs-cTn levels in patients with and without skeletal muscle disease.

  3 years

• Characterization of cTnT and cTnI on skeletal muscle biopsies from myopathic patients.

  1 year

• Characterization of the impact of cTnT and cTnI on the diagnosis and prognosis of muscle diseases

  3 years

Other Outcomes (7)

• Research on the development of a new cTnT-assay

  3 years

• Protein characterization

  3 years

• Cardiac troponin as predictors or screening tools for a cardiac involvement

  3 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

Consecutive participants which have been or currently are in treatment for a muscle disease at the University hospital of Basel, at the Canton Hospital of Aarau, University Hospital of Zürich or Bern or at the Medical University of Innsbruck, or who received a new diagnosis/suspicion of such a disease will be included.

You may qualify if:

• Diagnostic or suspicion of muscle disease as presence of specified keyword in patient's file or as screened by colleagues of the rheumatology, neuromuscular or other medical clinics.
• Patient consent available

You may not qualify if:

• Patient's refusal
• Age \<18 years old
• Terminal kidney insufficiency with need for dialysis.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Cantonal Hospital of Aarau, Switzerland: collaborator
• Medical University Innsbruck: collaborator
• University Hospital, Zürich: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (5)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Canton Hospital of Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

University Hospital Basel

Basel, 4056, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

University Hospital Zürich

Zurich, Switzerland

Location

Related Publications (3)

• Schmid J, Liesinger L, Birner-Gruenberger R, Stojakovic T, Scharnagl H, Dieplinger B, Asslaber M, Radl R, Beer M, Polacin M, Mair J, Szolar D, Berghold A, Quasthoff S, Binder JS, Rainer PP. Elevated Cardiac Troponin T in Patients With Skeletal Myopathies. J Am Coll Cardiol. 2018 Apr 10;71(14):1540-1549. doi: 10.1016/j.jacc.2018.01.070.

  PMID: 29622161 BACKGROUND

• Jaffe AS, Vasile VC, Milone M, Saenger AK, Olson KN, Apple FS. Diseased skeletal muscle: a noncardiac source of increased circulating concentrations of cardiac troponin T. J Am Coll Cardiol. 2011 Oct 18;58(17):1819-24. doi: 10.1016/j.jacc.2011.08.026. Epub 2011 Sep 29.

  PMID: 21962825 BACKGROUND

• du Fay de Lavallaz J, Prepoudis A, Wendebourg MJ, Kesenheimer E, Kyburz D, Daikeler T, Haaf P, Wanschitz J, Loscher WN, Schreiner B, Katan M, Jung HH, Maurer B, Hammerer-Lercher A, Mayr A, Gualandro DM, Acket A, Puelacher C, Boeddinghaus J, Nestelberger T, Lopez-Ayala P, Glarner N, Shrestha S, Manka R, Gawinecka J, Piscuoglio S, Gallon J, Wiedemann S, Sinnreich M, Mueller C; BASEL XII Investigators. Skeletal Muscle Disorders: A Noncardiac Source of Cardiac Troponin T. Circulation. 2022 Jun 14;145(24):1764-1779. doi: 10.1161/CIRCULATIONAHA.121.058489. Epub 2022 Apr 7.

  PMID: 35389756 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, muscle biopsies when clinically available

MeSH Terms

Conditions

Muscular Diseases; Muscle Weakness; Muscle Spasticity; Muscle Cramp; Myalgia; Muscular Atrophy

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Hypertonia; Musculoskeletal Pain; Pain; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Christian Mueller, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Angelika Hammerer, MD

  Canton Hospital Aarau

  PRINCIPAL INVESTIGATOR

• Julia Wanschitz, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

AU (1); CH (4)