Heart FailureCORELAB-CRTNCT02235766
Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
An observational study of Heart Failure, run by Kell s.r.l. at 4 sites in Italy.
Trial summary
Purpose of the observational study is to assess the capability of a satellite tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Echocardiographic assessment
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 4 sitesItaly
- Study dates
- Mar 2015to Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection fraction equal or less than 35% will be considered eligible to participate in this observational study.
Who may be able to join
- NYHA class II, III and ambulatory IV with:
- QRS complex duration ≥120msec;
- Ejection fraction ≤35%.
- Optimized medical treatment;
- Patient in sinus rhythm;
- Patient is willing and able to sign an informed consent form.
Who cannot join
- Unstable angina, or acute myocardial infarction, coronary-aortic bypass graft or percutaneous transluminal coronary angioplasty within the past 3 months;
- Cerebral vascular attacks or transient ischemic attack within the last month;
- Chronic atrial arrhythmias, paroxysmal atrial fibrillation events;
- Patients already implanted with an ICD or a CRT device;
- Pacemaker dependency or ventricular pacing percentage ≥10%;
- Valvular disease with an indication for surgical correction ≤12 months survival expectancy;
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- Mechanical right ventricular valve;
- Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints;
- Pregnancy or breastfeeding;
- Previous heart transplant;
- Refusal of study informed consent;
- Expected lack of compliance during follow-up;
- Patient is less than 18 years of age;
- Patient's life expectancy is less than 6 months in the opinion of physician.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
S.Camillo de Lellis Hospital
Rieti, 02100
Serafino Orazi, MD
Serafino Orazi, MD
- Recruiting
S.Eugenio Hospital
Rome, 00144
Filippo Lamberti, MD
Filippo Lamberti, MD
- Recruiting
University Hospital Campus Bio-Medico
Rome, 00144
Simona Mega, MD
Simona Mega, MD
- Recruiting
Fatebenefratelli Hospital
Rome, 00186
Gaetano Luca Panetta, MD
Gaetano Luca Panetta, MD
About this study
Purpose of the observational study is to assess the capability of a satellite tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality. Additionally the prognostic efficacy of specific echo parameters in the cardiac resynchronization therapy response will be evaluated.
Read the detailed description
CORELAB-CRT is a prospective multi center Italian observational study. All echo images and clips will be transmitted by using an integrated satellite transmission system. All echo assessments performed in accordance to the centers clinical practice will be also used to investigate the prognostic efficacy of echo parameters in term of response to the cardiac resynchronization therapy (CRT). All commercially available multi-chamber CRT-D devices from any manufacturers are allowed in this observational study.
Any compatible market released right atrial, right ventricular and left ventricular lead from any manufacturer is allowed.
The echocardiography device models used to perform echo imaging for all patients participating in this analysis are GE Vivid 7, GE Vivid 9 and GE Vivid I, according to the model used in the clinical practice of the hospital.
- Conditions
- Heart Failure
- Being tested
- Echocardiographic assessment
- Keywords
- Cardiac Resynchronization Therapy, Satellite Tele-Echocardiography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| CRT candidates patients | In accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection fraction equal or less than 35% will be considered eligible to participate in this observational study. Receives: Other: Echocardiographic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECM assessment
Agreement in the echocardiographic measurement capability (EMC) between transmitted and echocardiographic device image on the set of high quality images transmitted by STE. Each echo image will be classified as high quality image if the Mean Opinion Score (MOS) will be greater than 3 points. For each high quality echo image (MOS greater or equal 3) the EMC will be assessed to both transmitted and device echocardiographic image.
Measured: 6 months
Secondary outcomes (2)
Prognostic efficacy of specific echo parameters
Echocardiographic response defined as LVESV reduction ≥10% at 6 months after CRT-D implantation.
Measured: 6 months
Clinical composite score CCS
CCS describing patients regardless of vital status at 6 months and includes both objective and subjective measures of clinical status.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kell s.r.l.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Peraldo Neja, Principal investigator, CORELAB ResponsibleCesare Aragno, Study director, Kell s.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235766
- Sponsor's protocol ID
- Kell-1
- Acronym
- CORELAB-CRT
- Status last verified
- Mar 2016
- First submitted
- 3 Sep 2014
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
- ClinicalTrials.gov ID
- NCT02235766
- Acronym / sponsor ID
- CORELAB-CRT / Kell-1
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization Therapy, Satellite Tele-Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kell s.r.l.University, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 10 Sep 2014 (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.
Purpose of the observational study is to assess the capability of a satellite tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality. Additionally the prognostic efficacy of specific echo parameters in the cardiac resynchronization therapy response will be evaluated.
Detailed description
CORELAB-CRT is a prospective multi center Italian observational study. All echo images and clips will be transmitted by using an integrated satellite transmission system. All echo assessments performed in accordance to the centers clinical practice will be also used to investigate the prognostic efficacy of echo parameters in term of response to the cardiac resynchronization therapy (CRT). All commercially available multi-chamber CRT-D devices from any manufacturers are allowed in this observational study.
Any compatible market released right atrial, right ventricular and left ventricular lead from any manufacturer is allowed.
The echocardiography device models used to perform echo imaging for all patients participating in this analysis are GE Vivid 7, GE Vivid 9 and GE Vivid I, according to the model used in the clinical practice of the hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT candidates patients | – | Other: Echocardiographic assessmentIn accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection fraction equal or less than 35% will be considered eligible to participate in this observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection fraction equal or less than 35% will be considered eligible to participate in this observational study.
Key inclusion criteria (6 listed)
- NYHA class II, III and ambulatory IV with:
- Optimized medical treatment;
- Patient in sinus rhythm;
- Patient is willing and able to sign an informed consent form.
Key exclusion criteria (14 listed)
- Unstable angina, or acute myocardial infarction, coronary-aortic bypass graft or percutaneous transluminal coronary angioplasty within the past 3 months;
- Cerebral vascular attacks or transient ischemic attack within the last month;
- Chronic atrial arrhythmias, paroxysmal atrial fibrillation events;
- Patients already implanted with an ICD or a CRT device;
- Pacemaker dependency or ventricular pacing percentage ≥10%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiographic assessment | Other | CRT candidates patients |
Primary outcome
ECM assessment
Time frame: 6 months
Agreement in the echocardiographic measurement capability (EMC) between transmitted and echocardiographic device image on the set of high quality images transmitted by STE. Each echo image will be classified as high quality image if the Mean Opinion Score (MOS) will be greater than 3 points. For each high quality echo image (MOS greater or equal 3) the EMC will be assessed to both transmitted and device echocardiographic image.
2 secondary outcomes
Prognostic efficacy of specific echo parameters
Time frame: 6 months
Clinical composite score CCS
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
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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.
Carlo Peraldo Neja principal investigator
CORELAB Responsible
Cesare Aragno study director
Kell s.r.l.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Kell s.r.l. at 4 sites in Italy.
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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cesare Aragno (+39 06 36004916, caragno@kell.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECM assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2016.