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Personalized Risk Identification and Management for Arrhythmias and Heart Failure by 12 Lead Electrocardiogram and Cardiac Magnetic Resonance Imaging.


N/A
18 Years
70 Years
Open (Enrolling)
Both
General Hospital Population With Routine 12-lead ECG

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Trial Information

Personalized Risk Identification and Management for Arrhythmias and Heart Failure by 12 Lead Electrocardiogram and Cardiac Magnetic Resonance Imaging.


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.


Inclusion Criteria:



- -general hospital population with routine 12-lead ECG with abnormal repolarization
(wide QRS-T angle>100°) with validated measures of myocardial damage (Selvester QRS
score>5)

Exclusion Criteria:

- LVEF <35%

- age>70 years

- eGFR<45mL/min

- no ICD or PM

- no high risk of dying within 3 years from cancer, end stage cardiac, pulmonary,
immunologic or neurologic diseases

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Joao AC Lima, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

Johns Hopkins University

NCT ID:

NCT01353131

Start Date:

May 2010

Completion Date:

October 2016

Related Keywords:

  • General Hospital Population With Routine 12-lead ECG
  • electrocardiogram,
  • cardiac magnetic resonance
  • heart failure
  • sudden cardiac death
  • ECG scoring
  • Delayed enhancement
  • Arrhythmias, Cardiac
  • Heart Failure

Name

Location

Division of Cardiology, Johns Hopkins University School of MedicineBaltimore, Maryland  21287