Personalized Risk Identification and Management for Arrhythmias and Heart Failure by ECG and MRI
Condition: Inpatients and Outpatients With Routine 12-lead ECG
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Prevention of myocardial functional deterioration and sudden cardiac death among individuals
      of intermediate risk remains one of the most elusive frontiers of contemporary medicine.
      While most of these individuals are known to have had contact with the medical system, they
      are frequently not considered to be at high risk until far advanced along one or multiple
      disease processes leading to irreversible myocardial loss and electric instability. The goal
      of this proposal is to determine the prognostic power of combining specific measures of
      ventricular architecture, myocardial structure and electrical function for the early
      identification of individuals at risk to develop ventricular arrhythmias and progressive
      myocardial failure leading to severe cardiovascular outcomes and death.
    

Detailed description: 
      During C-TRIP Stage 1 we refined a risk stratification algorithm based on the electronic
      analysis of 69,088 routine 12-lead ECGs performed in a large medical institution during a 6
      month period by combining previously established indices of abnormal repolarization (wide
      QRS-T angle) with validated measures of myocardial damage (Selvester QRS score). Among
      patients considered at risk, 4.9% had perished 18 months later and among the survivors those
      > 70 years of age or with LV ejection fraction ≤ 35%, or at a high risk of dying within 3
      years from cancer, end stage cardiac, pulmonary, renal, immunologic or neurologic diseases,
      were excluded using a simple and reproducible screening arborescence based on the digital
      medical record. From the pool of remaining at risk patients derived from the application of
      the same screening methods in three other similarly large academic institutions, a sample of
      1100 individuals will be recruited for further risk stratification as participants of the
      C-TRIP Stage 2 prospective study. For C-TRIP Stage 2, patients will undergo detailed
      phenotypic studies including contrast-enhanced cardiac MRI, ECG Holter recordings at rest and
      during a 6 minute walk, signal averaged ECG and biomarkers of inflammation, myocardial
      ischemia and stress, as well as indices of collagen synthesis and turnover. Patients will be
      followed for 3 years for the development of a combined clinical outcome including mortality
      (all cause, cardiac and sudden cardiac death) and hospitalization for non-fatal myocardial
      infarction, acute coronary syndromes, ventricular arrhythmias and heart failure. From the
      combination of selected phenotypic markers of poor outcome, a risk score will be developed
      and used for the design of prophylactic strategies aimed at curbing premature sudden cardiac
      death and end-stage cardiac disease among patients currently classified as having
      intermediate levels of risk.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We refined a risk stratification algorithm based on the electronic analysis of 69,088
        routine 12-lead ECGs performed in a large medical institution during a 6 month period by
        combining previously established indices of abnormal repolarization (wide QRS-T angle) with
        validated measures of myocardial damage (Selvester QRS score).
      
Biospecimen description: 
      Whole blood, serum, plasma.
    
Keywords: electrocardiogram; cardiac magnetic resonance; heart failure; sudden cardiac death; ECG scoring; Delayed enhancement