Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reliability of Cardiac Troponins for the Diagnosis of Myocardial Infarction in the Presence of Skeletal Muscle Disease (H&M)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660969
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : May 5, 2021
Sponsor:
Collaborators:
Cantonal Hospital of Aarau, Switzerland
Medical University Innsbruck
University Hospital, Zürich
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date September 4, 2018
First Posted Date September 7, 2018
Last Update Posted Date May 5, 2021
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2018)
Comparison of cTnT and cTnI levels as measured by different hs-cTn assays in patients with skeletal muscle disease. [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 8, 2018)
  • Comparison of levels of cTnT and cTnI as measured by hs-assays in matched patients with and without skeletal muscle disease. [ Time Frame: 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. [ Time Frame: 1 year ]
  • Prognostic value of hs-cTn levels in patients with and without skeletal muscle disease. [ Time Frame: 3 years ]
  • Characterization of cTnT and cTnI on skeletal muscle biopsies from myopathic patients. [ Time Frame: 1 year ]
  • Characterization of the impact of cTnT and cTnI on the diagnosis and prognosis of muscle diseases [ Time Frame: 3 years ]
    Prognosis defined as the incidence of Major Cardiovascular Events (MACE is defined as a composite of death, acute myocardial infarction, life-threatening arrhythmia (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV) -block III), cardiac arrest/reanimation, acute heart failure (requiring admission to a hospital or intra-hospital transfer to the intensive care unit), stroke/transient ischemic attack, pulmonary embolism)
Original Secondary Outcome Measures
 (submitted: September 6, 2018)
  • Comparison of levels of cTnT and cTnI as measured by hs-assays in matched patients with and without skeletal muscle disease. [ Time Frame: 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. [ Time Frame: 1 year ]
  • Prognostic value of hs-cTn levels in patients with and without skeletal muscle disease. [ Time Frame: 3 years ]
  • Characterization of cTnT and cTnI on skeletal muscle biopsies from myopathic patients. [ Time Frame: 1 year ]
  • Characterization of the impact of cTnT and cTnI on the diagnosis and prognosis of muscle diseases [ Time Frame: 3 years ]
    Prognosis defined as the incidence of Major Cardiovascular Events (MACE is defined as a composite of death, acute myocardial infarction, life-threatening arrhythmia (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV) -block III), cardiac arrest/reanimation, acute heart failure (requiring admission to a hospital or intra-hospital transfer to the intensive care unit), stroke/TIA, pulmonary embolism)
Current Other Pre-specified Outcome Measures
 (submitted: September 6, 2018)
  • Research on the development of a new cTnT-assay [ Time Frame: 3 years ]
  • Protein characterization [ Time Frame: 3 years ]
  • Cardiac troponin as predictors or screening tools for a cardiac involvement [ Time Frame: 3 years ]
  • Cardiac troponin as predictor of evolution and therapeutic response of the muscle disease or muscle regeneration. [ Time Frame: 3 years ]
  • Characterisation of cardiac troponin in diseases of various etiologies involving muscles [ Time Frame: 3 years ]
  • Impact of muscle symptoms on cardiac troponin [ Time Frame: 3 years ]
  • Cardiac troponin versus other markers (e.g. CK) of inflammation/necrosis of peripheral muscles. [ Time Frame: 3 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Reliability of Cardiac Troponins for the Diagnosis of Myocardial Infarction in the Presence of Skeletal Muscle Disease
Official Title Heart&Muscle Study
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.

Detailed Description

Introduction: The detection of cardiomyocyte injury as quantified by blood concentrations of cardiac troponin T (cTnT) or I (cTnI) is central in the diagnosis of acute myocardial infarction (AMI). While multiple cardiac disorders other than AMI may also lead to cardiomyocyte injury and therefore elevations in cTnT and cTnI, latest generations of cTnT and cTnI assays are considered to have near exclusive cardiac-specificity. Overall, both analytes (cTnT and cTnI) seem to have comparable diagnostic accuracy among patients presenting with suspected AMI to the emergency department (ED). However, their use in the diagnosis of AMI in patients with a skeletal muscle disease is questioned, as especially cTnT was found to be elevated in this setting. These increased cTnT levels have been successively attributed to a possible re-expression of cTnT isoforms in the diseased muscle, to a primary cardiac involvement associated with the muscle disease or to a cross-reaction of the hs-cTnT assay with TnT of muscle origin.

Aim: To characterize cTn levels in patients with a skeletal muscle disease to assess their utility in the field of cardiology (through their implication in AMI diagnosis and their diagnostic and prognostic accuracy regarding a possible cardiac involvement) and in the field of neurology (for the detection and risk-stratification of the muscle disorder itself).

Methodology: This study will be conducted at the University Hospital of Basel, at the Kantonsspital Aarau, both in Switzerland, and at the University Hospital of Innsbruck, Austria. A prospective cohort patient will be recruited through the neurology, rheumatology and cardiology clinics of these three hospitals. This prospective cohort of patients presenting with skeletal muscle disease will allow us to systematically screen patients for cTn increases, to investigate the prevalence and characteristics of a possible primary cardiac involvement (as documented by electrocardiogram, echocardiography, magnetic resonance imaging, cTnI, NT-proBNP (N-terminal pro-B-type Natriuretic Peptide) and any available further cardiac testing) and to explore the origins of the elevated cTn levels using muscle biopsies. Furthermore, this prospective cohort will document the role of these biomarkers in the diagnosis, prognosis and risk-stratification of the muscle disease. Patients will receive a 1- and 3-year follow-up visit with blood draw in order to measure cTn and other biomarkers and record the impact of the evolution and treatment of the muscle disease on these levels. Major adverse cardiac events including cardiovascular death, AMI, hospitalization for heart failure, and the development of clinical or subclinical heart failure as quantified by elevated blood concentrations of NT-proBNP will be recorded during follow-up.

Potential significance: Elevated cTnT levels do not only have consequences regarding the diagnosis of AMI but also raise many questions regarding their possible use as a diagnostic, prognostic and risk-stratification marker regarding the different muscle injuries and their possible primary cardiac involvement.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples, muscle biopsies when clinically available
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 or at the Medical University of Innsbruck, or who received a new diagnosis/suspicion of such a disease will be included.
Condition
  • Myopathy
  • Muscle Weakness
  • Muscle Damage
  • Muscle Spasticity
  • Muscle Cramp
  • Muscle Injury
  • Muscle Soreness
  • Muscle Atrophy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 29, 2021)
600
Original Estimated Enrollment
 (submitted: September 6, 2018)
130
Estimated Study Completion Date January 1, 2027
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient's refusal
  • Age <18 years old
  • Terminal kidney insufficiency with need for dialysis.
  • Temporary exclusion criteria : Acute health condition such as myocardial infarction, patients presenting with a major trauma, a sepsis, patients shortly after cardiac surgery, and patients in shock (>100 bpm, <90 systolic BP, evidence of organ dysfunction).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jeanne du Fay de Lavallaz, MD +41 61 2652525 (Zentrale) jeanne.dufaydelavallaz@usb.ch
Contact: Christian Mueller, MD +41 61 328 6549 christian.mueller@usb.ch
Listed Location Countries Austria,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03660969
Other Study ID Numbers BASEL XII
Research Grant ( Other Grant/Funding Number: Swiss Heart Foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Christian Müller, MD, University Hospital, Basel, Switzerland
Study Sponsor Christian Müller, MD
Collaborators
  • Cantonal Hospital of Aarau, Switzerland
  • Medical University Innsbruck
  • University Hospital, Zürich
Investigators
Principal Investigator: Christian Mueller, MD University Hospital, Basel, Switzerland
Principal Investigator: Angelika Hammerer, MD Canton Hospital Aarau
Principal Investigator: Julia Wanschitz, MD Medical University Innsbruck
PRS Account University Hospital, Basel, Switzerland
Verification Date April 2021