Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease

NCT05241418 | Recruiting

• 1 other identifier: P00040666
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this research study the investigators want to learn more about how well the investigators can visualize scar tissue in the heart by MRI. In patients with congenital heart disease who need a procedure in the electrophysiology laboratory, how the MRI findings match the findings in the electrophysiology laboratory is not known. This study works to answer these questions. Participants will undergo a cardiac MRI as part of the routine clinical care that was ordered by their doctors and additional imaging by cardiac MRI will be performed.

Conditions

Congenital Heart Disease; Fibrosis Myocardial; Fibrosis; Heart

Keywords

Late gadolinium enhancement; 3D late gadolinium enhancement; atrial late gadolinium enhancement; Cardiac MRI; Congenital heart disease

Outcome Measures

Primary Outcomes (1)

• Total atrial fibrosis content from 3D-LGE-CMR

  Atrial 3D-LGE-CMR images will be post-processed using the Circle ADAS 3D software module (Circle Cardiovascular Inc., Calgary, AB, Canada) and analyzed to identify fibrotic tissue. Results are portrayed as 3D-colored maps and as a calculated percentage of atrial fibrosis relative to total atrial surface area. All CMR images will be analyzed by two observers for the calculation of interrater reliability of the percent of atrial LGE. One observer will perform contours twice for the purposes of intra-observer agreement.

  1 year

Secondary Outcomes (2)

• Total atrial fibrosis content from catheter-derived endocardial bipolar voltage map.

  2 years

• Sustained atrial arrhythmia, defined as IART/AF lasting >30 seconds detected on ECG, ambulatory monitor, or inpatient telemetry

  5 years

Study Arms (1)

Patients with congenital heart disease undergoing a cardiac MRI with Gadolinium

Patients with congenital heart disease who are undergoing a clinically-ordered cardiac MRI and as part of that MRI the contrast agent, Gadolinium, will be administered.

Diagnostic Test: Atrial 3D late gadolinium enhancement

Interventions

Atrial 3D late gadolinium enhancement DIAGNOSTIC_TEST

We will use cardiac MRI to take a picture of the atria. This picture will be used to identify scar tissue within the atria.

Also known as: Atrial 3D LGE

Patients with congenital heart disease undergoing a cardiac MRI with Gadolinium

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The hospital at which the investigators are based is a referral center for patients with congenital heart disease. These patients sometimes require a cardiac MRI. Patients \>13 years old with congenital heart disease referred for CMR and meeting eligibility criteria will be approached for this study.

You may qualify if:

• Patients \>13 years old with congenital heart disease referred for cardiac MRI and receiving gadolinium as part of routine clinical care or for pre-ablation planning will be included.

You may not qualify if:

• Those with self-reported anxiety or claustrophobia and/or the presence of a permanent pacemaker or implantable cardioverter defibrillator will be excluded.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02130, United States

RECRUITING

Related Publications (9)

• Bouchardy J, Therrien J, Pilote L, Ionescu-Ittu R, Martucci G, Bottega N, Marelli AJ. Atrial arrhythmias in adults with congenital heart disease. Circulation. 2009 Oct 27;120(17):1679-86. doi: 10.1161/CIRCULATIONAHA.109.866319. Epub 2009 Oct 12.

  PMID: 19822808 BACKGROUND

• Labombarda F, Hamilton R, Shohoudi A, Aboulhosn J, Broberg CS, Chaix MA, Cohen S, Cook S, Dore A, Fernandes SM, Fournier A, Kay J, Macle L, Mondesert B, Mongeon FP, Opotowsky AR, Proietti A, Rivard L, Ting J, Thibault B, Zaidi A, Khairy P; AARCC. Increasing Prevalence of Atrial Fibrillation and Permanent Atrial Arrhythmias in Congenital Heart Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):857-865. doi: 10.1016/j.jacc.2017.06.034.

  PMID: 28797355 BACKGROUND

• Akoum N, Fernandez G, Wilson B, Mcgann C, Kholmovski E, Marrouche N. Association of atrial fibrosis quantified using LGE-MRI with atrial appendage thrombus and spontaneous contrast on transesophageal echocardiography in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2013 Oct;24(10):1104-9. doi: 10.1111/jce.12199. Epub 2013 Jul 11.

  PMID: 23844972 BACKGROUND

• Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.

  PMID: 24496537 BACKGROUND

• Chelu MG, King JB, Kholmovski EG, Ma J, Gal P, Marashly Q, AlJuaid MA, Kaur G, Silver MA, Johnson KA, Suksaranjit P, Wilson BD, Han FT, Elvan A, Marrouche NF. Atrial Fibrosis by Late Gadolinium Enhancement Magnetic Resonance Imaging and Catheter Ablation of Atrial Fibrillation: 5-Year Follow-Up Data. J Am Heart Assoc. 2018 Dec 4;7(23):e006313. doi: 10.1161/JAHA.117.006313.

  PMID: 30511895 BACKGROUND

• King JB, Azadani PN, Suksaranjit P, Bress AP, Witt DM, Han FT, Chelu MG, Silver MA, Biskupiak J, Wilson BD, Morris AK, Kholmovski EG, Marrouche N. Left Atrial Fibrosis and Risk of Cerebrovascular and Cardiovascular Events in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Sep 12;70(11):1311-1321. doi: 10.1016/j.jacc.2017.07.758.

  PMID: 28882227 BACKGROUND

• Chubb H, Aziz S, Karim R, Sohns C, Razeghi O, Williams SE, Whitaker J, Harrison J, Chiribiri A, Schaeffter T, Wright M, O'Neill M, Razavi R. Optimization of late gadolinium enhancement cardiovascular magnetic resonance imaging of post-ablation atrial scar: a cross-over study. J Cardiovasc Magn Reson. 2018 May 3;20(1):30. doi: 10.1186/s12968-018-0449-8.

  PMID: 29720202 BACKGROUND

• Rivas-Gandara N, Dos-Subira L, Francisco-Pascual J, Rodriguez-Garcia J, Pijuan-Domenech A, Benito B, Valente F, Pascual-Gonzalez G, Santos-Ortega A, Miranda B, Perez-Rodon J, Ribera-Sole A, Burcet-Rodriguez G, Roses-Noguer F, Gordon B, Rodriguez-Palomares J, Ferreira-Gonzalez I. Substrate characterization of the right ventricle in repaired tetralogy of Fallot using late enhancement cardiac magnetic resonance. Heart Rhythm. 2021 Nov;18(11):1868-1875. doi: 10.1016/j.hrthm.2021.05.032. Epub 2021 Jun 19.

  PMID: 34098087 BACKGROUND

• Ghonim S, Ernst S, Keegan J, Giannakidis A, Spadotto V, Voges I, Smith GC, Boutsikou M, Montanaro C, Wong T, Ho SY, McCarthy KP, Shore DF, Dimopoulos K, Uebing A, Swan L, Li W, Pennell DJ, Gatzoulis MA, Babu-Narayan SV. Three-Dimensional Late Gadolinium Enhancement Cardiovascular Magnetic Resonance Predicts Inducibility of Ventricular Tachycardia in Adults With Repaired Tetralogy of Fallot. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008321. doi: 10.1161/CIRCEP.119.008321. Epub 2020 Oct 6.

  PMID: 33022183 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Fibrosis

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel A Castellanos, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel A Castellanos, MD

CONTACT

6173557769; daniel.castellanos@cardio.chboston.org

Edward O'Leary, MD

CONTACT

6173557275; Edward.OLeary@cardio.chboston.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 15, 2022
• Study Start: March 23, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)