Inpatients and Outpatients With Routine 12-lead ECGPRIMERINCT01353131
Personalized Risk Identification and Management for Arrhythmias and Heart Failure by ECG and MRI
An observational study of Inpatients and Outpatients With Routine 12-lead ECG, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inpatients and Outpatients With Routine 12-lead ECG
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Cardiology, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Personalized Risk Identification and Management for Arrhythmias and Heart Failure by 12 Lead Electrocardiogram and Cardiac Magnetic Resonance Imaging.
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.
Read the 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.
- Keywords
- electrocardiogram, cardiac magnetic resonance, heart failure, sudden cardiac death, ECG scoring, Delayed enhancement
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startMay 2010
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inpatients and Outpatients With Routine 12-lead ECGStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joao AC Lima, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353131
- Sponsor's protocol ID
- NA_00031964
- Acronym
- PRIMERI
- Status last verified
- Nov 2018
- First submitted
- 11 May 2011
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mewton N, Strauss DG, Rizzi P, Verrier RL, Liu CY, Tereshchenko LG, Nearing B, Volpe GJ, Marchlinski FE, Moxley J, Killian T, Wu KC, Spooner P, Lima JA. Screening for Cardiac Magnetic Resonance Scar Features by 12-Lead ECG, in Patients with Preserved Ejection Fraction. Ann Noninvasive Electrocardiol. 2016 Jan;21(1):49-59. doi: 10.1111/anec.12264.
PubMed 26806840Murthy S, Rizzi P, Mewton N, Strauss DG, Liu CY, Volpe GJ, Marchlinski FE, Spooner P, Berger RD, Kellman P, Lima JA, Tereshchenko LG. Number of P-wave fragmentations on P-SAECG correlates with infiltrated atrial fat. Ann Noninvasive Electrocardiol. 2014 Mar;19(2):114-21. doi: 10.1111/anec.12084. Epub 2013 Sep 9.
PubMed 24620844Tereshchenko LG, Rizzi P, Mewton N, Volpe GJ, Murthy S, Strauss DG, Liu CY, Marchlinski FE, Spooner P, Berger RD, Kellman P, Lima JA. Infiltrated atrial fat characterizes underlying atrial fibrillation substrate in patients at risk as defined by the ARIC atrial fibrillation risk score. Int J Cardiol. 2014 Mar 1;172(1):196-201. doi: 10.1016/j.ijcard.2014.01.012. Epub 2014 Jan 22.
PubMed 24485635
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Risk Identification and Management for Arrhythmias and Heart Failure by 12 Lead Electrocardiogram and Cardiac Magnetic Resonance Imaging.
- ClinicalTrials.gov ID
- NCT01353131
- Acronym / sponsor ID
- PRIMERI / NA_00031964
- Keywords
- electrocardiogram, cardiac magnetic resonance, heart failure, sudden cardiac death, ECG scoring, Delayed enhancement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 26806840Mewton N, Strauss DG, Rizzi P, Verrier RL, Liu CY, Tereshchenko LG, Nearing B, Volpe GJ, Marchlinski FE, Moxley J, Killian T, Wu KC, Spooner P, Lima JA. Screening for Cardiac Magnetic Resonance Scar Features by 12-Lead ECG, in Patients with Preserved Ejection Fraction. Ann Noninvasive Electrocardiol. 2016 Jan;21(1):49-59. doi: 10.1111/anec.12264.
- Derived from this study: PubMed 24620844Murthy S, Rizzi P, Mewton N, Strauss DG, Liu CY, Volpe GJ, Marchlinski FE, Spooner P, Berger RD, Kellman P, Lima JA, Tereshchenko LG. Number of P-wave fragmentations on P-SAECG correlates with infiltrated atrial fat. Ann Noninvasive Electrocardiol. 2014 Mar;19(2):114-21. doi: 10.1111/anec.12084. Epub 2013 Sep 9.
- Derived from this study: PubMed 24485635Tereshchenko LG, Rizzi P, Mewton N, Volpe GJ, Murthy S, Strauss DG, Liu CY, Marchlinski FE, Spooner P, Berger RD, Kellman P, Lima JA. Infiltrated atrial fat characterizes underlying atrial fibrillation substrate in patients at risk as defined by the ARIC atrial fibrillation risk score. Int J Cardiol. 2014 Mar 1;172(1):196-201. doi: 10.1016/j.ijcard.2014.01.012. Epub 2014 Jan 22.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joao AC Lima, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inpatients and Outpatients With Routine 12-lead ECG, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01353131, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.