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Atrial FibrillationCRYPTONITENCT01025947

"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)"

An observational study of Atrial Fibrillation and Stroke, run by University of Valencia at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

STUDY TYPE: Prospective, national , multicenter, and observational study. OBJECTIVE: To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years. Read more about this study

Who is it for?
Ages 45 to 85 years
Conditions the study is for
Atrial Fibrillation, Stroke
How many people
100 participants
Where
2 sitesSpain
Study dates
Mar 2009to Mar 2013
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 45 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted for detection of atrial fibrillation

Who may be able to join

  • All patients included must meet one of these two conditions:
  • Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging.
  • First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria
  • All patients must meet all of the following:
  • The patient has been implanted an ILR within 30 days after qualifying event
  • Age between 45-85 years
Show all 11Show fewer
  • No stenosis >50% in any arterial vessel corresponding to the affected territory
  • Normal Echocardiography
  • Normal 24 hours EKG Holter recording
  • Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography)
  • Acceptance and signature of Patient Informed Consent.

Who cannot join

  • All patients included cannot meet any of the following conditions:
  • Recurrent stroke or TIA
  • Stroke or TIA with determined etiology according to TOAST criteria.
  • Anticoagulation indication at the time of enrollment in the study.
  • Total contraindication for anticoagulation therapy
  • Atrial fibrillation detection prior to enrollment
Show all 11Show fewer
  • Severe cognitive impairment or dementia
  • Patient unable to be followed up
  • Patients enrolled in another clinical trial
  • Patients with life expectancy of less than 1 year
  • Pregnancy

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: Observational Study on Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder

STUDY TYPE:

Prospective, national , multicenter, and observational study.

OBJECTIVE:

To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years.

DEVICE:

Reveal XT 9529 (SQDM)

SAMPLE SIZE AND STUDY DURATION:

100 patients enrolled which will be followed during a period of 2 years.

Read the detailed description

Observational study in patients with cryptogenic stroke (TOAST criteria) and with an implanted EKG loop recorder, with the primary objective of knowing the atrial fibrillation incidence in this population

Keywords
Atrial fibrillation, Cryptogenic stroke, Implantable loop recorder
Medical subject headings
Atrial Fibrillation, Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01025947
Study groupRoleWhat they receive
Study groupPatients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes.

    Measured: Patients will be followed up during two years, regardless of reaching or not the primary endpoint.

Secondary outcomes (4)

  1. All subsequent AF episodes detected by the ILR after primary outcome (AF burden)

    Measured: Patients will be followed up during two years

  2. AF episodes detected by external monitoring

    Measured: Patients will be followed up during two years

  3. Presence of stroke, recurrent TIA, or silent infarction in neuroimaging

    Measured: Patients will be followed up during two years

  4. Changes in anticoagulant therapy

    Measured: Patients will be followed up during two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2013
  4. Study completionMar 2013

Why it stopped: Responsible party does not work at UV anymore

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01025947
Sponsor's protocol ID
HCUV
Acronym
CRYPTONITE
Status last verified
Jun 2010
First submitted
3 Dec 2009
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No

Publications

  • Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available.

    PubMed 17194875

  • Carandang R, Seshadri S, Beiser A, Kelly-Hayes M, Kase CS, Kannel WB, Wolf PA. Trends in incidence, lifetime risk, severity, and 30-day mortality of stroke over the past 50 years. JAMA. 2006 Dec 27;296(24):2939-46. doi: 10.1001/jama.296.24.2939.

    PubMed 17190894

  • Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.

    PubMed 7678184

  • Adams HP Jr, Davis PH, Leira EC, Chang KC, Bendixen BH, Clarke WR, Woolson RF, Hansen MD. Baseline NIH Stroke Scale score strongly predicts outcome after stroke: A report of the Trial of Org 10172 in Acute Stroke Treatment (TOAST). Neurology. 1999 Jul 13;53(1):126-31. doi: 10.1212/wnl.53.1.126.

    PubMed 10408548

  • Sacco RL, Ellenberg JH, Mohr JP, Tatemichi TK, Hier DB, Price TR, Wolf PA. Infarcts of undetermined cause: the NINCDS Stroke Data Bank. Ann Neurol. 1989 Apr;25(4):382-90. doi: 10.1002/ana.410250410.

    PubMed 2712533

  • Jabaudon D, Sztajzel J, Sievert K, Landis T, Sztajzel R. Usefulness of ambulatory 7-day ECG monitoring for the detection of atrial fibrillation and flutter after acute stroke and transient ischemic attack. Stroke. 2004 Jul;35(7):1647-51. doi: 10.1161/01.STR.0000131269.69502.d9. Epub 2004 May 20.

    PubMed 15155965

  • Douen AG, Pageau N, Medic S. Serial electrocardiographic assessments significantly improve detection of atrial fibrillation 2.6-fold in patients with acute stroke. Stroke. 2008 Feb;39(2):480-2. doi: 10.1161/STROKEAHA.107.492595. Epub 2008 Jan 3.

    PubMed 18174488

  • Liao J, Khalid Z, Scallan C, Morillo C, O'Donnell M. Noninvasive cardiac monitoring for detecting paroxysmal atrial fibrillation or flutter after acute ischemic stroke: a systematic review. Stroke. 2007 Nov;38(11):2935-40. doi: 10.1161/STROKEAHA.106.478685. Epub 2007 Sep 27.

    PubMed 17901394

  • Solano A, Menozzi C, Maggi R, Donateo P, Bottoni N, Lolli G, Tomasi C, Croci F, Oddone D, Puggioni E, Brignole M. Incidence, diagnostic yield and safety of the implantable loop-recorder to detect the mechanism of syncope in patients with and without structural heart disease. Eur Heart J. 2004 Jul;25(13):1116-9. doi: 10.1016/j.ehj.2004.05.013.

    PubMed 15231369

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Stroke, run by University of Valencia at 2 sites 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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study was stopped early (reason given: Responsible party does not work at UV anymore). Results are not available in the source record.

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?

First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes. (time frame: Patients will be followed up during two years, regardless of reaching or not the primary endpoint.). 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 NCT01025947, which also lists 9 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 8 Jul 2026.

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CRYPTONITE Clinical Trial NCT01025947 | AzTrials