Myocardial InfarctionDEVELOP-VTNCT04599439
CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)
An observational study of Myocardial Infarction and Myocardial Infarction Old, run by Centro Medico Teknon at 1 site in Spain.
Trial summary
Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Myocardial Infarction Old, Arrhythmias, Cardiac
- What is being tested?
- Cardiac magnetic resonance imaging
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2020to 30 Sep 2025
- How long will I take part?
- 2 Years
- 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: All patients with chronic (> 3 months after the index coronary event), stable ischemic heart disease, irrespectively of the LVEF, will be included.
Who may be able to join
- Age > 18 years.
- Chronic (> 3 months after the index coronary event), stable ischemic heart disease, irrespectively of the LVEF.
- Life expectancy of > 1 year with a good functional status.
- Signed informed consent.
Who cannot join
- Age < 18 years.
- Pregnancy.
- Life expectancy of < 1 year, or bad functional status (NYHA IV functional class).
- Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
- Previously documented sustained ventricular arrhythmias.
- Impossibility or contraindications to undergo a contrast-enhanced CMR study.
- Concomitant investigation treatments.
- Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Antonio Berruezo, MD, PhD
Barcelona, 08022
Antonio Berruezo, MD, PhD, (+34) 93 290 62 51, antonio.berruezo@quironsalud.es
Beatriz Jáuregui, MD, (+34) 93 290 62 51, beatriz.jauregui@quironsalud.es
About this study
Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (> 5% of the left ventricular -LV- mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from sustained monomorphic ventricular tachycardias (SMVT) than in matched controls for age, sex, infarct location, and left ventricular ejection fraction (LVEF). However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of sudden cardiac death (SCD). In a recent, case-control study, we identified the border zone channel (BZC) mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical, Barcelona, Spain), with FDA 510(k) Clearance and European Community Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of approx. 2 years.
In the present cohort study, we sought to evaluate the usefulness of the BZC mass measurement to predict the occurrence of VT events in a prospective, multicenter, unselected series of consecutive chronic ischemic patients without previous arrhythmia evidence, irrespectively of their LVEF.
- Conditions
- Myocardial Infarction, Myocardial Infarction Old, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Arrythmia, Sudden Cardiac Death
- Being tested
- Cardiac magnetic resonance imaging
- Keywords
- myocardial infarction, cardiac magnetic resonance imaging, scar arrhythmogenicity, ventricular arrhythmias, sudden cardiac death, border zone channels
- Medical subject headings
- Myocardial Infarction, Arrhythmias, Cardiac, Tachycardia, Ventricular, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance imagingDiagnostic test
All patients will undergo a cardiac magnetic resonance test to calculate their border zone channel (BZC) mass. This will not be used to decide further interventions, but all the patients will be treated according to standards of care.
| Study group | Role | What they receive |
|---|---|---|
| High arrhythmia risk | Patients with a cardiac magnetic resonance-derived border zone channel (BZC) mass > 5.15 g will be considered at highest risk for developing ventricular arrhythmias (VA) or sudden cardiac death (SCD). Receives: Diagnostic Test: Cardiac magnetic resonance imaging | |
| Low arrhythmia risk | Patients with a cardiac magnetic resonance-derived border zone channel (BZC) mass < 5.15 g will be considered at lowest risk for developing ventricular arrhythmias (VA) or sudden cardiac death (SCD). Receives: Diagnostic Test: Cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular arrhythmias or sudden cardiac death
Clinical composite of cardiac death or any sustained ventricular arrhythmia after a 2-year follow-up period.
Measured: 2 years
Secondary outcomes (2)
Non-cardiac causes of mortality
Death due to non-cardiac conditions
Measured: 2 years
Heart failure hospitalization rate
Hospitalization due to decompensated heart failure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Aug 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
- Investigators
- Antonio Berruezo, MD, PhD, Principal investigator, Centro Médico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599439
- Sponsor's protocol ID
- DEVELOP-VT
- Acronym
- DEVELOP-VT
- Status last verified
- Aug 2023
- First submitted
- 17 Oct 2020
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Bakker JM, van Capelle FJ, Janse MJ, Wilde AA, Coronel R, Becker AE, Dingemans KP, van Hemel NM, Hauer RN. Reentry as a cause of ventricular tachycardia in patients with chronic ischemic heart disease: electrophysiologic and anatomic correlation. Circulation. 1988 Mar;77(3):589-606. doi: 10.1161/01.cir.77.3.589.
PubMed 3342490Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ. Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet. 2001 Jan 6;357(9249):21-8. doi: 10.1016/S0140-6736(00)03567-4.
PubMed 11197356Schmidt A, Azevedo CF, Cheng A, Gupta SN, Bluemke DA, Foo TK, Gerstenblith G, Weiss RG, Marban E, Tomaselli GF, Lima JA, Wu KC. Infarct tissue heterogeneity by magnetic resonance imaging identifies enhanced cardiac arrhythmia susceptibility in patients with left ventricular dysfunction. Circulation. 2007 Apr 17;115(15):2006-14. doi: 10.1161/CIRCULATIONAHA.106.653568. Epub 2007 Mar 26.
PubMed 17389270Yan AT, Shayne AJ, Brown KA, Gupta SN, Chan CW, Luu TM, Di Carli MF, Reynolds HG, Stevenson WG, Kwong RY. Characterization of the peri-infarct zone by contrast-enhanced cardiac magnetic resonance imaging is a powerful predictor of post-myocardial infarction mortality. Circulation. 2006 Jul 4;114(1):32-9. doi: 10.1161/CIRCULATIONAHA.106.613414. Epub 2006 Jun 26.
PubMed 16801462Klem I, Weinsaft JW, Bahnson TD, Hegland D, Kim HW, Hayes B, Parker MA, Judd RM, Kim RJ. Assessment of myocardial scarring improves risk stratification in patients evaluated for cardiac defibrillator implantation. J Am Coll Cardiol. 2012 Jul 31;60(5):408-20. doi: 10.1016/j.jacc.2012.02.070.
PubMed 22835669Perez-David E, Arenal A, Rubio-Guivernau JL, del Castillo R, Atea L, Arbelo E, Caballero E, Celorrio V, Datino T, Gonzalez-Torrecilla E, Atienza F, Ledesma-Carbayo MJ, Bermejo J, Medina A, Fernandez-Aviles F. Noninvasive identification of ventricular tachycardia-related conducting channels using contrast-enhanced magnetic resonance imaging in patients with chronic myocardial infarction: comparison of signal intensity scar mapping and endocardial voltage mapping. J Am Coll Cardiol. 2011 Jan 11;57(2):184-94. doi: 10.1016/j.jacc.2010.07.043.
PubMed 21211689Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
PubMed 11907286Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.
PubMed 15659722Andreu D, Ortiz-Perez JT, Fernandez-Armenta J, Guiu E, Acosta J, Prat-Gonzalez S, De Caralt TM, Perea RJ, Garrido C, Mont L, Brugada J, Berruezo A. 3D delayed-enhanced magnetic resonance sequences improve conducting channel delineation prior to ventricular tachycardia ablation. Europace. 2015 Jun;17(6):938-45. doi: 10.1093/europace/euu310. Epub 2015 Jan 23.
PubMed 25616406Andreu D, Berruezo A, Ortiz-Perez JT, Silva E, Mont L, Borras R, de Caralt TM, Perea RJ, Fernandez-Armenta J, Zeljko H, Brugada J. Integration of 3D electroanatomic maps and magnetic resonance scar characterization into the navigation system to guide ventricular tachycardia ablation. Circ Arrhythm Electrophysiol. 2011 Oct;4(5):674-83. doi: 10.1161/CIRCEP.111.961946. Epub 2011 Aug 31.
PubMed 21880674Zeitler EP, Al-Khatib SM, Friedman DJ, Han JY, Poole JE, Bardy GH, Bigger JT, Buxton AE, Moss AJ, Lee KL, Dorian P, Cappato R, Kadish AH, Kudenchuk PJ, Mark DB, Inoue LYT, Sanders GD. Predicting appropriate shocks in patients with heart failure: Patient level meta-analysis from SCD-HeFT and MADIT II. J Cardiovasc Electrophysiol. 2017 Nov;28(11):1345-1351. doi: 10.1111/jce.13307. Epub 2017 Aug 23.
PubMed 28744959Acosta J, Fernandez-Armenta J, Borras R, Anguera I, Bisbal F, Marti-Almor J, Tolosana JM, Penela D, Andreu D, Soto-Iglesias D, Evertz R, Matiello M, Alonso C, Villuendas R, de Caralt TM, Perea RJ, Ortiz JT, Bosch X, Serra L, Planes X, Greiser A, Ekinci O, Lasalvia L, Mont L, Berruezo A. Scar Characterization to Predict Life-Threatening Arrhythmic Events and Sudden Cardiac Death in Patients With Cardiac Resynchronization Therapy: The GAUDI-CRT Study. JACC Cardiovasc Imaging. 2018 Apr;11(4):561-572. doi: 10.1016/j.jcmg.2017.04.021. Epub 2017 Aug 2.
PubMed 28780194Ikeda T, Yoshino H, Sugi K, Tanno K, Shimizu H, Watanabe J, Kasamaki Y, Yoshida A, Kato T. Predictive value of microvolt T-wave alternans for sudden cardiac death in patients with preserved cardiac function after acute myocardial infarction: results of a collaborative cohort study. J Am Coll Cardiol. 2006 Dec 5;48(11):2268-74. doi: 10.1016/j.jacc.2006.06.075. Epub 2006 Nov 9.
PubMed 17161258Gatzoulis KA, Tsiachris D, Arsenos P, Antoniou CK, Dilaveris P, Sideris S, Kanoupakis E, Simantirakis E, Korantzopoulos P, Goudevenos I, Flevari P, Iliodromitis E, Sideris A, Vassilikos V, Fragakis N, Trachanas K, Vernardos M, Konstantinou I, Tsimos K, Xenogiannis I, Vlachos K, Saplaouras A, Triantafyllou K, Kallikazaros I, Tousoulis D. Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: the PRESERVE EF study. Eur Heart J. 2019 Sep 14;40(35):2940-2949. doi: 10.1093/eurheartj/ehz260.
PubMed 31049557
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)
- ClinicalTrials.gov ID
- NCT04599439
- Acronym / sponsor ID
- DEVELOP-VT / DEVELOP-VT
- Conditions
- Myocardial Infarction, Myocardial Infarction Old, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Arrythmia, Sudden Cardiac Death
- Keywords
- myocardial infarction, cardiac magnetic resonance imaging, scar arrhythmogenicity, ventricular arrhythmias, sudden cardiac death, border zone channels
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 22 Oct 2020 (actual)
- 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.
Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (> 5% of the left ventricular -LV- mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from sustained monomorphic ventricular tachycardias (SMVT) than in matched controls for age, sex, infarct location, and left ventricular ejection fraction (LVEF). However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of sudden cardiac death (SCD). In a recent, case-control study, we identified the border zone channel (BZC) mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical, Barcelona, Spain), with FDA 510(k) Clearance and European Community Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of approx. 2 years.
In the present cohort study, we sought to evaluate the usefulness of the BZC mass measurement to predict the occurrence of VT events in a prospective, multicenter, unselected series of consecutive chronic ischemic patients without previous arrhythmia evidence, irrespectively of their LVEF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High arrhythmia risk | – | Diagnostic Test: Cardiac magnetic resonance imagingPatients with a cardiac magnetic resonance-derived border zone channel (BZC) mass > 5.15 g will be considered at highest risk for developing ventricular arrhythmias (VA) or sudden cardiac death (SCD). |
| Low arrhythmia risk | – | Diagnostic Test: Cardiac magnetic resonance imagingPatients with a cardiac magnetic resonance-derived border zone channel (BZC) mass < 5.15 g will be considered at lowest risk for developing ventricular arrhythmias (VA) or sudden cardiac death (SCD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with chronic (> 3 months after the index coronary event), stable ischemic heart disease, irrespectively of the LVEF, will be included.
Key inclusion criteria (4 listed)
- Age > 18 years.
- Chronic (> 3 months after the index coronary event), stable ischemic heart disease, irrespectively of the LVEF.
- Life expectancy of > 1 year with a good functional status.
- Signed informed consent.
Key exclusion criteria (8 listed)
- Age < 18 years.
- Pregnancy.
- Life expectancy of < 1 year, or bad functional status (NYHA IV functional class).
- Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
- Previously documented sustained ventricular arrhythmias.
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 |
|---|---|---|
| Cardiac magnetic resonance imagingAll patients will undergo a cardiac magnetic resonance test to calculate their border zone channel (BZC) mass. This will not be used to decide further interventions, but all the patients will be treated according to standards of care. | Diagnostic test | High arrhythmia risk, Low arrhythmia risk |
Primary outcome
Ventricular arrhythmias or sudden cardiac death
Time frame: 2 years
Clinical composite of cardiac death or any sustained ventricular arrhythmia after a 2-year follow-up period.
2 secondary outcomes
Non-cardiac causes of mortality
Time frame: 2 years
Heart failure hospitalization rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 3342490de Bakker JM, van Capelle FJ, Janse MJ, Wilde AA, Coronel R, Becker AE, Dingemans KP, van Hemel NM, Hauer RN. Reentry as a cause of ventricular tachycardia in patients with chronic ischemic heart disease: electrophysiologic and anatomic correlation. Circulation. 1988 Mar;77(3):589-606. doi: 10.1161/01.cir.77.3.589.
- Background: PubMed 11197356Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ. Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet. 2001 Jan 6;357(9249):21-8. doi: 10.1016/S0140-6736(00)03567-4.
- Background: PubMed 17389270Schmidt A, Azevedo CF, Cheng A, Gupta SN, Bluemke DA, Foo TK, Gerstenblith G, Weiss RG, Marban E, Tomaselli GF, Lima JA, Wu KC. Infarct tissue heterogeneity by magnetic resonance imaging identifies enhanced cardiac arrhythmia susceptibility in patients with left ventricular dysfunction. Circulation. 2007 Apr 17;115(15):2006-14. doi: 10.1161/CIRCULATIONAHA.106.653568. Epub 2007 Mar 26.
- Background: PubMed 16801462Yan AT, Shayne AJ, Brown KA, Gupta SN, Chan CW, Luu TM, Di Carli MF, Reynolds HG, Stevenson WG, Kwong RY. Characterization of the peri-infarct zone by contrast-enhanced cardiac magnetic resonance imaging is a powerful predictor of post-myocardial infarction mortality. Circulation. 2006 Jul 4;114(1):32-9. doi: 10.1161/CIRCULATIONAHA.106.613414. Epub 2006 Jun 26.
- Background: PubMed 22835669Klem I, Weinsaft JW, Bahnson TD, Hegland D, Kim HW, Hayes B, Parker MA, Judd RM, Kim RJ. Assessment of myocardial scarring improves risk stratification in patients evaluated for cardiac defibrillator implantation. J Am Coll Cardiol. 2012 Jul 31;60(5):408-20. doi: 10.1016/j.jacc.2012.02.070.
- Background: PubMed 21211689Perez-David E, Arenal A, Rubio-Guivernau JL, del Castillo R, Atea L, Arbelo E, Caballero E, Celorrio V, Datino T, Gonzalez-Torrecilla E, Atienza F, Ledesma-Carbayo MJ, Bermejo J, Medina A, Fernandez-Aviles F. Noninvasive identification of ventricular tachycardia-related conducting channels using contrast-enhanced magnetic resonance imaging in patients with chronic myocardial infarction: comparison of signal intensity scar mapping and endocardial voltage mapping. J Am Coll Cardiol. 2011 Jan 11;57(2):184-94. doi: 10.1016/j.jacc.2010.07.043.
- Background: PubMed 11907286Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
- Background: PubMed 15659722Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. doi: 10.1056/NEJMoa043399.
- Background: PubMed 25616406Andreu D, Ortiz-Perez JT, Fernandez-Armenta J, Guiu E, Acosta J, Prat-Gonzalez S, De Caralt TM, Perea RJ, Garrido C, Mont L, Brugada J, Berruezo A. 3D delayed-enhanced magnetic resonance sequences improve conducting channel delineation prior to ventricular tachycardia ablation. Europace. 2015 Jun;17(6):938-45. doi: 10.1093/europace/euu310. Epub 2015 Jan 23.
- Background: PubMed 21880674Andreu D, Berruezo A, Ortiz-Perez JT, Silva E, Mont L, Borras R, de Caralt TM, Perea RJ, Fernandez-Armenta J, Zeljko H, Brugada J. Integration of 3D electroanatomic maps and magnetic resonance scar characterization into the navigation system to guide ventricular tachycardia ablation. Circ Arrhythm Electrophysiol. 2011 Oct;4(5):674-83. doi: 10.1161/CIRCEP.111.961946. Epub 2011 Aug 31.
- Background: PubMed 28744959Zeitler EP, Al-Khatib SM, Friedman DJ, Han JY, Poole JE, Bardy GH, Bigger JT, Buxton AE, Moss AJ, Lee KL, Dorian P, Cappato R, Kadish AH, Kudenchuk PJ, Mark DB, Inoue LYT, Sanders GD. Predicting appropriate shocks in patients with heart failure: Patient level meta-analysis from SCD-HeFT and MADIT II. J Cardiovasc Electrophysiol. 2017 Nov;28(11):1345-1351. doi: 10.1111/jce.13307. Epub 2017 Aug 23.
- Background: PubMed 28780194Acosta J, Fernandez-Armenta J, Borras R, Anguera I, Bisbal F, Marti-Almor J, Tolosana JM, Penela D, Andreu D, Soto-Iglesias D, Evertz R, Matiello M, Alonso C, Villuendas R, de Caralt TM, Perea RJ, Ortiz JT, Bosch X, Serra L, Planes X, Greiser A, Ekinci O, Lasalvia L, Mont L, Berruezo A. Scar Characterization to Predict Life-Threatening Arrhythmic Events and Sudden Cardiac Death in Patients With Cardiac Resynchronization Therapy: The GAUDI-CRT Study. JACC Cardiovasc Imaging. 2018 Apr;11(4):561-572. doi: 10.1016/j.jcmg.2017.04.021. Epub 2017 Aug 2.
- Individual participant dataSharing planned: No
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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.
Antonio Berruezo, MD, PhD principal investigator
Centro Médico Teknon
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 Myocardial Infarction Old, run by Centro Medico Teknon at 1 site in Spain.
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 4 inclusion and 8 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 31 Aug 2023. 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 Spain. 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 Antonio Berruezo, MD, PhD ((+34) 93 290 62 51, antonio.berruezo@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular arrhythmias or sudden cardiac death (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04599439, which also lists 14 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 31 Aug 2023.