Myocardial InfarctionESCAPE-ICDNCT01422174
Clinical Registry on Sudden Death Primary Prevention at Latin America
An observational study of Myocardial Infarction and Sudden Death, run by Biotronik SE & Co. KG at 1 site in Argentina.
Trial summary
INTRODUCTION: Sudden cardiac death is one of the most important reasons of death at industrialized countries. Despite its importance, nowadays Clinical Guidelines are not as extended as expected, with respect to indications for primary prevention defibrillator implantation, following MADIT II and MUSTT criteria… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Sudden Death
- What is being tested?
- Implantable Cardio Defibrillator (ICD),
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2012to Jan 2015
- 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: Patients at Latin American countries that fulfill MADIT, MADIT II and/or MUSTT criteria.
Who may be able to join
- Patients that had Acute Myocardial Infarction (>40 days post-AMI) documented with the presence of Q-wave or cardiac-specific enzymatic markers of myocardial necrosis (CK-MB/troponin), occurred within 3 years previous to enrollment / after June 2008.
- Left Ventricular Ejection Fraction (LVEF) ≤40% post-revascularization (if no revascularization, measurement performed <3 months previous to patient enrollment, >40 days post-AMI and >3 months post-revascularization -if applicable-).
Who cannot join
- Patient with an implanted ICD
- <18 years old
- Pregnant or breast feeding women
- Patients that are already participating in other Investigational Study or Registry
- Non signed patient informed consent or refusal from patient's reference physician to patient participation
- Patient inability to comply with protocol (assist to scheduled follow-ups), due to: residence displacement out of center's activity area; unstable geographical situation or at very long distance from the center; unstable medical and/or psychological condition
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- Cardiac transplanted (or in transplant waiting list)
- Severe Heart Failure (or other co-morbidity: cancer, renal failure, etc.)
- Life expectancy lower than 1 year
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Centro Privado de Cardiologia
San Miguel de Tucumán, Tucumán Province
About this study
Official title: Clinical Registry on Sudden Death Primary Prevention at Latin America (rEgiStro Clinico en America Latina de Prevencion Primaria en muErte Subita)
INTRODUCTION: Sudden cardiac death is one of the most important reasons of death at industrialized countries. Despite its importance, nowadays Clinical Guidelines are not as extended as expected, with respect to indications for primary prevention defibrillator implantation, following MADIT II and MUSTT criteria, especially at Latin American countries.
OBJECTIVES: This Project is designed with the purpose of providing tools to help spreading primary prevention by the means of clinical evidence on real risk of death in this group of patients.
Read more
REGISTRY DESIGN:
- retrospective (at stage 1); prospective (at stage 2)
- multi-center (minimum 25-30 centres)
- international (Argentina, Brazil, Colombia, Chile, Mexico and Venezuela)
- non randomized.
- Sample size: at screening about 12.500 patients and 962 patients at treatment stage
REGISTRY DEVICES: CE marked (Conformité Européenne) single-chamber, dual-chamber or CRT (Cardiac Resynchronization Therapy) implantable cardiac defibrillator (ICD).
Read the detailed description
REGISTRY STAGES 2 stages will be performed:
- Stage 1 (Screening): 12500 patients with MI and LVEF<40% will be evaluated, to know ICD implantation prevalence in such patients at Latin American countries
- Stage 2 (Treatment): after patient screening and as per clinical decision, 962 patients will be entered in group 1 and 2 (481 each, 1:1)
STEERING COMMITTEE
- Dr. Sergio Dubner. Clinica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires - Argentina
- Dr. William Uribe. CES CARDIOLOGIA. Medellin - Colombia
CLINICAL ASSESSMENT
- Dr Francisco Javier Alzueta Rodriguez. Hospital Clinico Universitario Virgen de la Victoria. Malaga - Spain
REGISTRY DURATION
- Patient enrollment period initiation: September 2011
- End of patient enrollment: September 2013
- End of FUs: September 2018
- Registry closure and data analyses: 4Q 2018.
REGULATORY CONSIDERATIONS As this is an observational registry, no submission to National Authorities is required.
- Conditions
- Myocardial Infarction, Sudden Death
- Being tested
- Implantable Cardio Defibrillator (ICD),
- Keywords
- Primary prevention, Latin America, Sudden death, Myocardial infarction, Ejection Fraction, ICD
- Medical subject headings
- Myocardial Infarction, Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardio Defibrillator (ICD),Procedure or surgery
Also called CE approved devices
Standard ICD implantation (as per clinical decision)
| Study group | Role | What they receive |
|---|---|---|
| ICD implantation | Patients that receive an ICD implantation (non randomized, by clinical decision) will enter this group Receives: Procedure: Implantable Cardio Defibrillator (ICD), | |
| Non ICD implantation | Patients that do not receive ICD implantation (non randomized, by clinical decision); they can receive any other treatment (e.g. antiarrhythmic drugs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of patients with MADIT, MADIT II and MUST at Latin American countries
Primary Outcome at Stage 1: Determine prevalence of patients with myocardial infarction and high risk of sudden death at Latin America, that fulfill inclusion criteria
Primary Outcome at Stage 2: Compare MACE development in patients that receive ICD implantation vs patients that receive other type of treatment (non ICD)
Measured: Patients that suffered from MI in the last 3 years and during the enrollment period
Secondary outcomes (1)
Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring
Measured: 5 years (until end 2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startMar 2012
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Why it stopped: Study stopped due to lost of interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Cohort
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergio J Dubner, MD, FACC, Principal investigator, Clínica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires, ArgentinaWilliam Uribe, MD, Principal investigator, CES Cardiología. Medellin, ColombiaFrancisco J Alzueta Rodriguez (Study Clinical Advisor), Dr, Study chair, Hospital Clínico Universitario Virgen de la Victoria. Málaga, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422174
- Sponsor's protocol ID
- TA098
- Acronym
- ESCAPE-ICD
- Status last verified
- Mar 2015
- First submitted
- 18 Aug 2011
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registry on Sudden Death Primary Prevention at Latin America (rEgiStro Clinico en America Latina de Prevencion Primaria en muErte Subita)
- ClinicalTrials.gov ID
- NCT01422174
- Acronym / sponsor ID
- ESCAPE-ICD / TA098
- Conditions
- Myocardial Infarction, Sudden Death
- Keywords
- Primary prevention, Latin America, Sudden death, Myocardial infarction, Ejection Fraction, ICD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study stopped due to lost of interest.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 23 Aug 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.
INTRODUCTION: Sudden cardiac death is one of the most important reasons of death at industrialized countries. Despite its importance, nowadays Clinical Guidelines are not as extended as expected, with respect to indications for primary prevention defibrillator implantation, following MADIT II and MUSTT criteria, especially at Latin American countries.
OBJECTIVES: This Project is designed with the purpose of providing tools to help spreading primary prevention by the means of clinical evidence on real risk of death in this group of patients.
REGISTRY DESIGN:
- retrospective (at stage 1); prospective (at stage 2)
- multi-center (minimum 25-30 centres)
- international (Argentina, Brazil, Colombia, Chile, Mexico and Venezuela)
- non randomized.
- Sample size: at screening about 12.500 patients and 962 patients at treatment stage
REGISTRY DEVICES: CE marked (Conformité Européenne) single-chamber, dual-chamber or CRT (Cardiac Resynchronization Therapy) implantable cardiac defibrillator (ICD).
Detailed description
REGISTRY STAGES 2 stages will be performed:
- Stage 1 (Screening): 12500 patients with MI and LVEF<40% will be evaluated, to know ICD implantation prevalence in such patients at Latin American countries
- Stage 2 (Treatment): after patient screening and as per clinical decision, 962 patients will be entered in group 1 and 2 (481 each, 1:1)
STEERING COMMITTEE
- Dr. Sergio Dubner. Clinica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires - Argentina
- Dr. William Uribe. CES CARDIOLOGIA. Medellin - Colombia
CLINICAL ASSESSMENT
- Dr Francisco Javier Alzueta Rodriguez. Hospital Clinico Universitario Virgen de la Victoria. Malaga - Spain
REGISTRY DURATION
- Patient enrollment period initiation: September 2011
- End of patient enrollment: September 2013
- End of FUs: September 2018
- Registry closure and data analyses: 4Q 2018.
REGULATORY CONSIDERATIONS As this is an observational registry, no submission to National Authorities is required.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICD implantation | – | Procedure: Implantable Cardio Defibrillator (ICD),Patients that receive an ICD implantation (non randomized, by clinical decision) will enter this group |
| Non ICD implantation | – | –Patients that do not receive ICD implantation (non randomized, by clinical decision); they can receive any other treatment (e.g. antiarrhythmic drugs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Latin American countries that fulfill MADIT, MADIT II and/or MUSTT criteria.
Key inclusion criteria (2 listed)
- Patients that had Acute Myocardial Infarction (>40 days post-AMI) documented with the presence of Q-wave or cardiac-specific enzymatic markers of myocardial necrosis (CK-MB/troponin), occurred within 3 years previous to enrollment / after June 2008.
- Left Ventricular Ejection Fraction (LVEF) ≤40% post-revascularization (if no revascularization, measurement performed <3 months previous to patient enrollment, >40 days post-AMI and >3 months post-revascularization -if applicable-).
Key exclusion criteria (9 listed)
- Patient with an implanted ICD
- <18 years old
- Pregnant or breast feeding women
- Patients that are already participating in other Investigational Study or Registry
- Non signed patient informed consent or refusal from patient's reference physician to patient participation
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 |
|---|---|---|
| Implantable Cardio Defibrillator (ICD),Also: CE approved devicesStandard ICD implantation (as per clinical decision) | Procedure or surgery | ICD implantation |
Primary outcome
Prevalence of patients with MADIT, MADIT II and MUST at Latin American countries
Time frame: Patients that suffered from MI in the last 3 years and during the enrollment period
Primary Outcome at Stage 1: Determine prevalence of patients with myocardial infarction and high risk of sudden death at Latin America, that fulfill inclusion criteria Primary Outcome at Stage 2: Compare MACE development in patients that receive ICD implantation vs patients that receive other type of treatment (non ICD)
1 secondary outcome
Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring
Time frame: 5 years (until end 2018)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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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.
Sergio J Dubner, MD, FACC principal investigator
Clínica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires, Argentina
William Uribe, MD principal investigator
CES Cardiología. Medellin, Colombia
Francisco J Alzueta Rodriguez (Study Clinical Advisor), Dr study chair
Hospital Clínico Universitario Virgen de la Victoria. Málaga, Spain
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 Myocardial Infarction and Sudden Death, run by Biotronik SE & Co. KG at 1 site in Argentina.
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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Mar 2015. 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 Argentina. 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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Prevalence of patients with MADIT, MADIT II and MUST at Latin American countries (time frame: Patients that suffered from MI in the last 3 years and during the enrollment period). 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 3 Mar 2015.