Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke

NCT06542770 | Recruiting DMC FDA Device

• 1 other identifier: CRIPTO-FAST
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF. The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.

Conditions

Paroxysmal Atrial Fibrillation; Cardiac Rhythm Disorder; Left Atrial Dilatation; Cryptogenic Stroke

Keywords

Atrial strain. Implantable cardiac monitor

Outcome Measures

Primary Outcomes (1)

• Detection atrial fibrilation at follow-up

  defined by the presence of a confirmatory 12-leads ECG, or a registration lasting more than 30 seconds in, either the 72h-Holter-Monitoring, or in the ICM recording. In case of AF detection OAC was initiated immediately.

  Up to 2 years follow-up (ICM and standard care practice)

Secondary Outcomes (5)

• LA indexed volume

  Before Day 3 since the Criptogenic Stroke

• Maximum Systolic Global Longitudinal Strain (PALs)

  Before Day 3 since the Criptogenic Stroke

• Atrial Contraction Strain (PACs)

  Before Day 3 since the Criptogenic Stroke

• Atrial Ejection Fraction

  Before Day 3 since the Criptogenic Stroke

• stroke recurrences

  Up to 2 years follow-up (ICM and standard care practice)

Study Arms (4)

Atrial cardiomyopathy by echocardiogram intervention

EXPERIMENTAL

Presence of Atrial cardiomyopathy is defined by echocardiogram if ANY of the following is present: 1. LA dilatation: indexed volumen \>32 ml/m2 2. PALS (Peak atrial longitudinal strain) \<21% 3. PACS ( Peak atrial contraction strain ) \<13% 4. Atrial ejection fraction \<55%

Device: Early implant of cardiac monitor

Atrial cardiomyopathy by echocardiogram standard practice

NO INTERVENTION

Presence of Atrial cardiomyopathy is defined by echocardiogram if ANY of the following is present: 1. LA dilatation: indexed volumen \>32 ml/m2 2. PALS (Peak atrial longitudinal strain) \<21% 3. PACS ( Peak atrial contraction strain ) \<13% 4. Atrial ejection fraction \<55%

Non atrial cardiomyopathy by echocardiogram intervention

EXPERIMENTAL

Absence of atrial cardiomyopathy is defined by echocardiogram if none of the characteristics bellow were accomplished. 1. LA dilatation: indexed volumen \>32 ml/m2 2. PALS (Peak atrial longitudinal strain) \<21% 3. PACS ( Peak atrial contraction strain ) \<13% 4. Atrial ejection fraction \<55%

Device: Early implant of cardiac monitor

Non atrial cardiomyopathy by echocardiogram standard practice

NO INTERVENTION

Absence of atrial cardiomyopathy defined by echocardiogram if none of the characteristics bellow were accomplished. 1. LA dilatation: indexed volumen \>32 ml/m2 2. PALS (Peak atrial longitudinal strain) \<21% 3. PACS ( Peak atrial contraction strain ) \<13% 4. Atrial ejection fraction \<55%

Interventions

Early implant of cardiac monitor DEVICE

ICM implant 3-4 days after the stroke and prior to discharge. All devices (Abbott Confirm or Jot) were implanted subcutaneously under local anaesthesia in the left chest region and programmed with an specific algorithm for AF detection set at 30 seconds for detection. All patients were included in remote monitoring system (Merlin), which was programmed to send alerts in case of registering episodes qualifying for AF detection, and a monthly routine registration. All ICM recordings were reviewed by a specialized cardiologist.

Atrial cardiomyopathy by echocardiogram intervention; Non atrial cardiomyopathy by echocardiogram intervention

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023
• Age between 50 and 89 years;
• Undetermined origin at hospital admission according to the SSS-TOAST criteria (2):
• Absence of major structural heart disease by cardiac ultrasound (normal global and segmental left ventricle contraction, absence of valvular/rheumatic disease, absence of intracardiac shunts)
• Absence of AF during 48h ECG-monitoring
• Absence of major anomalies in the supra-aortic trunks ultrasound.

You may not qualify if:

• Patients with a history of hemorrhagic stroke;
• Presence with prior atrial fibrillation or atrial flutter;
• Permanent contraindication or indication for OAC for other reasons;
• Recent (\<1 month) major surgery or cardiac events;
• Presence of severe cardiac abnormalities;
• Patients with life expectancy \<1 year or severe stroke (modified Rankin Scale \> 4).

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Related Publications (15)

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  PMID: 23364221 BACKGROUND

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  PMID: 25748102 BACKGROUND

• Rubiera M, Aires A, Antonenko K, Lemeret S, Nolte CH, Putaala J, Schnabel RB, Tuladhar AM, Werring DJ, Zeraatkar D, Paciaroni M. European Stroke Organisation (ESO) guideline on screening for subclinical atrial fibrillation after stroke or transient ischaemic attack of undetermined origin. Eur Stroke J. 2022 Sep;7(3):VI. doi: 10.1177/23969873221099478. Epub 2022 Jun 3.

  PMID: 36082257 BACKGROUND

• Cuadrado-Godia E, Benito B, Ois A, Valles E, Rodriguez-Campello A, Giralt-Steinhauer E, Cabrera S, Alcalde O, Jimenez-Lopez J, Jimenez-Conde J, Marti-Almor J, Roquer J. Ultra-early continuous cardiac monitoring improves atrial fibrillation detection and prognosis of patients with cryptogenic stroke. Eur J Neurol. 2020 Feb;27(2):244-250. doi: 10.1111/ene.14061. Epub 2019 Sep 18.

  PMID: 31424609 BACKGROUND

• Klijn CJ, Paciaroni M, Berge E, Korompoki E, Korv J, Lal A, Putaala J, Werring DJ. Antithrombotic treatment for secondary prevention of stroke and other thromboembolic events in patients with stroke or transient ischemic attack and non-valvular atrial fibrillation: A European Stroke Organisation guideline. Eur Stroke J. 2019 Sep;4(3):198-223. doi: 10.1177/2396987319841187. Epub 2019 Apr 9.

  PMID: 31984228 BACKGROUND

• Pagola J, Juega J, Francisco-Pascual J, Bustamante A, Penalba A, Pala E, Rodriguez M, De Lera-Alfonso M, Arenillas JF, Cabezas JA, Moniche F, de Torres R, Montaner J, Gonzalez-Alujas T, Alvarez-Sabin J, Molina CA; Crypto-AF study group. Predicting Atrial Fibrillation with High Risk of Embolization with Atrial Strain and NT-proBNP. Transl Stroke Res. 2021 Oct;12(5):735-741. doi: 10.1007/s12975-020-00873-2. Epub 2020 Nov 13.

  PMID: 33184686 BACKGROUND

• Albers GW, Bernstein RA, Brachmann J, Camm J, Easton JD, Fromm P, Goto S, Granger CB, Hohnloser SH, Hylek E, Jaffer AK, Krieger DW, Passman R, Pines JM, Reed SD, Rothwell PM, Kowey PR. Heart Rhythm Monitoring Strategies for Cryptogenic Stroke: 2015 Diagnostics and Monitoring Stroke Focus Group Report. J Am Heart Assoc. 2016 Mar 15;5(3):e002944. doi: 10.1161/JAHA.115.002944. No abstract available.

  PMID: 27068633 BACKGROUND

• Rubio Campal JM, Garcia Torres MA, Sanchez Borque P, Navas Vinagre I, Zamarbide Capdepon I, Miracle Blanco A, Bravo Calero L, Saez Pinel R, Tunon Fernandez J, Serratosa Fernandez JM. Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (from the DAF-ESUS registry). Am J Cardiol. 2020 Feb 1;125(3):409-414. doi: 10.1016/j.amjcard.2019.10.050. Epub 2019 Nov 6.

  PMID: 31780074 BACKGROUND

• Marks D, Ho R, Then R, Weinstock JL, Teklemariam E, Kakadia B, Collins J, Andriulli J, Hunter K, Ortman M, Russo AM. Real-world experience with implantable loop recorder monitoring to detect subclinical atrial fibrillation in patients with cryptogenic stroke: The value of p wave dispersion in predicting arrhythmia occurrence. Int J Cardiol. 2021 Mar 15;327:86-92. doi: 10.1016/j.ijcard.2020.11.019. Epub 2020 Nov 10.

  PMID: 33186666 BACKGROUND

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  PMID: 32600783 BACKGROUND

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• Lumikari TJ, Putaala J, Kerola A, Sibolt G, Pirinen J, Pakarinen S, Lehto M, Nieminen T. Continuous 4-week ECG monitoring with adhesive electrodes reveals AF in patients with recent embolic stroke of undetermined source. Ann Noninvasive Electrocardiol. 2019 Sep;24(5):e12649. doi: 10.1111/anec.12649. Epub 2019 May 2.

  PMID: 31045315 BACKGROUND

• Kalani R, Bernstein R, Passman R, Curran Y, Ruff I, Prabhakaran S. Factual Inaccuracies Contained in the Article Entitled "Low Yield of Mobile Cardiac Outpatient Telemetry after Cryptogenic Stroke in Patients with Extensive Cardiac Imaging". J Stroke Cerebrovasc Dis. 2017 Dec;26(12):3035. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.018. Epub 2017 Oct 18. No abstract available.

  PMID: 29054732 BACKGROUND

• Ziegler PD, Rogers JD, Ferreira SW, Nichols AJ, Richards M, Koehler JL, Sarkar S. Long-term detection of atrial fibrillation with insertable cardiac monitors in a real-world cryptogenic stroke population. Int J Cardiol. 2017 Oct 1;244:175-179. doi: 10.1016/j.ijcard.2017.06.039. Epub 2017 Jun 10.

  PMID: 28624331 BACKGROUND

• Ziegler PD, Rogers JD, Ferreira SW, Nichols AJ, Sarkar S, Koehler JL, Warman EN, Richards M. Real-World Experience with Insertable Cardiac Monitors to Find Atrial Fibrillation in Cryptogenic Stroke. Cerebrovasc Dis. 2015;40(3-4):175-81. doi: 10.1159/000439063. Epub 2015 Aug 28.

  PMID: 26314298 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Ischemic Stroke

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Ermengol Valles Gras, PhD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ermengol Valles Gras, PhD

CONTACT

932 48 3118; evalles@psmar.cat

Ana Beatriz Garcia Duran, MD

CONTACT

932 48 3118; 62242@psmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of arrhythmias

Model Details: Randomized prospective parallel study

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: August 7, 2024
• Study Start: January 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the publication and during 10 years
• Access Criteria: Upon reasonable request

Locations

ES (1)