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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by Johns Hopkins University
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01353131
First received: May 11, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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
General Hospital Population 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 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: April 2012 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353131

Contacts
Contact: Kathleen Lensch, AM 4105027818 klensch@jhmi.edu

Locations
United States, Maryland
Division of Cardiology, Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Joao AC Lima, MD, PhD    410-614-1284    jlima@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Joao AC Lima, MD, PhD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joao AC Lima, Johns Hopkins University, School of Medicine
ClinicalTrials.gov Identifier: NCT01353131     History of Changes
Other Study ID Numbers: Johns Hopkins University
Study First Received: May 11, 2011
Last Updated: May 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on October 01, 2014