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Personalized Risk Identification and Management for Arrhythmias and Heart Failure by ECG and MRI (PRIMERI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Joao A.C Lima, Johns Hopkins University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353131
First Posted: May 12, 2011
Last Update Posted: September 2, 2015
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Joao A.C Lima, Johns Hopkins University
  Purpose
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.

Condition
Inpatients and Outpatients With Routine 12-lead ECG

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Personalized Risk Identification and Management for Arrhythmias and Heart Failure by 12 Lead Electrocardiogram and Cardiac Magnetic Resonance Imaging.

Resource links provided by NLM:


Further study details as provided by Joao A.C Lima, Johns Hopkins University:

Biospecimen Retention:   Samples Without DNA
Whole blood, serum, plasma.

Estimated Enrollment: 160
Study Start Date: May 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
ECG Screening
1000 patients with moderate to high risk determined by 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) excluding 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 excluded on clinical data obtained through medical record.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353131


Locations
United States, Maryland
Division of Cardiology, Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Joao AC Lima, MD, PhD Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joao A.C Lima, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01353131     History of Changes
Other Study ID Numbers: Johns Hopkins University
First Submitted: May 11, 2011
First Posted: May 12, 2011
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by Joao A.C Lima, Johns Hopkins University:
electrocardiogram,
cardiac magnetic resonance
heart failure
sudden cardiac death
ECG scoring
Delayed enhancement

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases