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Arrhythmia AtrialAFRICATNCT03188484

Atrial Fibrillation Research In CATalonia

An observational study of Arrhythmia Atrial and Atrial Fibrillation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The AFRICAT study is a prospective, multicenter, population-based study, which aims to create and apply a sequential screening program for atrial fibrillation (AF) in a high-risk population by integrating clinical, electrocardiographic and biological information. Read more about this study

Who is it for?
Ages 65 to 75 yearsHealthy volunteers can take part
How many people
492 participants
Where
2 sitesSpain
Study dates
May 2016to Oct 2019
How long will I take part?
5 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 65 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: All people included were managed by the Public Health System. Therefore 5,000 participants aged 65-75 with active diagnoses of hypertension (I10) and diabetes (E10.9 E11.9) will be selected from the electronic health record of Primary Care. Given that the registered prevalence of Atrial Fibrillation in this population is was 7.3%, the investigators estimated that around 2.8% will be newly diagnosed with AF at the first study visit. Therefore, the investigators estimate that the number of patients in this population who have undiagnosed AF might be from 140 to 210 patients, taking into account that AF detection should be improved in the study given the long-term monitoring.

Who may be able to join

  • All patients aged 65-75 with active diagnoses of hypertension (I10) and diabetes (E10.9 E11.9)

Who cannot join

  • Absence or not accessibility to singular person or its clinical record or/and difficulty to follow the instructions about how managing the devices or/and no acceptation of conditions
  • Chronic inflammatory diseases
  • Active Cancer
  • Dementia
  • For Phases II-III: previous diagnosis of AF

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • SAP Muntanya

    Barcelona, 08035

  • SAP Terres de l'Ebre

    Tortosa, Tarragona, 43500

Other trials in Spain

About this study

Official title: Stepwise High Risk Individuals Screening for Atrial Fibrillation Using Sequential Clinical-electro-biological Register: the AFRICAT Study (Atrial Fibrillation Research In CATalonia)

The AFRICAT study is a prospective, multicenter, population-based study, which aims to create and apply a sequential screening program for atrial fibrillation (AF) in a high-risk population by integrating clinical, electrocardiographic and biological information. The study will be divided into three different phases of generation, validation and application of a screening program.

In Phase I, from 8,000 individuals aged 65-75 with hypertension and diabetes identified from primary center registries, 100 will be randomly selected . In these patients, the investigators will complete clinical assessment, testing of different pulse-handheld ECG devices (MyDiagnostik, AliveCor and WatchBP) for AF screening, discovery of blood biomarkers for AF (by aptamer technology and RNA expression), and validation of biological candidates from the literature and previous results. All patients will receive Holter monitoring with a wearable device (NuuboTM). In parallel, a predictive risk model for AF will be developed from historical records from the areas in which the study will be carried out.

Read more

This Phase I will be followed by a Phase II-validation phase of 400 patients, selected by the predictive model previously mentioned, belonging to the top risk quartile. In these patients, the best biomarkers and devices from phase I will be validated, and patients will be again monitored with the wearable Holter device.

With the results from this validation analysis, a screening program (Phase III) based in the combination of clinical predictors, devices to detect AF (handheld-ECG or pulse wave detectors), blood biomarkers determination and long-term monitoring with wearable Holter. This program will be applied over the whole population targeted by the AFRICAT study, which corresponds to 8,000 patients from 65 to 75 years old, whit hypertension and diabetes mellitus as comorbidities.

Read the detailed description

The study has been approved by the Ethics Committee of Research Institute IDIAP Jordi Gol (P15/047/2015) and by Hospital Universitari Vall d'Hebron Clinical Research Ethics Committee (PR(AG)133-2015). The study will be conducted in compliance with the Declaration of Helsinki. Registry information was collected from the government-run healthcare provider responsible for all inpatient care in Catalonia. All participants will receive written information and thereafter sign informed consent before inclusion, will be selected among the electronic registers from two different health areas in Catalonia, and will be identified by their 10-digit personal identification number assigned to all citizens in Catalonia.

These patients will be given an appointment in their primary care centre and will receive a comprehensive assessment consisting of:

  • Clinical characteristics: demographic factors (age, gender, habits); vascular risk factors (hypertension, diabetes, dyslipidemia), medications, comorbidities (especially those related to AF such as coronary disease, heart failure), vital signs (blood pressure, glycaemia, weight and height).
  • Electrocardiographic assessment: three different devices will be tested on each participant (MyDiasnostik, AliveCor and WatchBP). A conventional ECG will be performed to be compared with the results from these devices.
  • Blood sample collection: a blood sample of 32 cc divided into two serum tubes (8.5 cc), two plasma EDTA tubes (6 cc) and one TempusTM RNA tube (3 cc). Samples will be processed and stored at -20 ºC at the recruiting centre until shipment to Neurovascular Research Laboratory, where the sample bank will be set up.
  • Holter ECG monitoring: a Nuubo Holter will be given to each patient to be carried for four weeks. Electrocardiographic devices will be read blindly. The device records, anonymized and encrypted, will be sent for blinded reading to the Rhythm Disorders Unit from Hospital Virgen del Rocio in Seville.
Keywords
Atrial Fibrillation, Electrocardiography, Biological Markers, Risk Assessment
Medical subject headings
Atrial Fibrillation, Hypertension, Diabetes Mellitus

What is being measured

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

  1. Atrial fibrillation (AF) diagnosis

    Absence of discrete P waves together with an irregular, arrhythmic pattern of ventricular activation, more than 30 seconds.

    Measured: Study visit/1 month monitoring

Timeline

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

  1. First posted15 Jun 2017
  2. Study startMay 2016
  3. Primary completionApr 2017
  4. Study completionOct 2019

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
Ecologic or community
Time perspective
Prospective
Enrolment
492 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03188484
Sponsor's protocol ID
IDIAP Jordi Gol
Other IDs
275/C/2015
Acronym
AFRICAT
Status last verified
Apr 2022
First submitted
13 Jun 2017
Last updated
11 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Abellana R, Gonzalez-Loyola F, Verdu-Rotellar JM, Bustamante A, Pala E, Clua-Espuny JL, Montaner J, Pedrote A, Del Val-Garcia JL, Ribas Segui D, Munoz MA. Predictive model for atrial fibrillation in hypertensive diabetic patients. Eur J Clin Invest. 2021 Dec;51(12):e13633. doi: 10.1111/eci.13633. Epub 2021 Jun 19.

    PubMed 34148231

  • Clua-Espuny JL, Muria-Subirats E, Ballesta-Ors J, Lorman-Carbo B, Clua-Queralt J, Pala E, Lechuga-Duran I, Gentille-Lorente D, Bustamante A, Munoz MA, Montaner J; AFRICAT Research Group. Risk of Atrial Fibrillation, Ischemic Stroke and Cognitive Impairment: Study of a Population Cohort >/=65 Years of Age. Vasc Health Risk Manag. 2020 Oct 28;16:445-454. doi: 10.2147/VHRM.S276477. eCollection 2020.

    PubMed 33149596

  • Garcia-Berrocoso T, Pala E, Consegal M, Piccardi B, Negro A, Gill N, Penalba A, Huerga Encabo H, Fernandez-Cadenas I, Meisel A, Meisel C, Jickling GC, Munoz MA, Clua-Espuny JL, Pedrote A, Pagola J, Juega J, Bustamante A, Montaner J. Cardioembolic Ischemic Stroke Gene Expression Fingerprint in Blood: a Systematic Review and Verification Analysis. Transl Stroke Res. 2020 Jun;11(3):326-336. doi: 10.1007/s12975-019-00730-x. Epub 2019 Sep 2.

    PubMed 31475302

  • Muria-Subirats E, Clua-Espuny JL, Ballesta-Ors J, Lorman-Carbo B, Lechuga-Duran I, Fernandez-Saez J, Pla-Farnos R, On Behalf Members Of Africat Group. Incidence and Risk Assessment for Atrial Fibrillation at 5 Years: Hypertensive Diabetic Retrospective Cohort. Int J Environ Res Public Health. 2020 May 16;17(10):3491. doi: 10.3390/ijerph17103491.

    PubMed 32429492

  • Pala E, Bustamante A, Clua-Espuny JL, Acosta J, Gonzalez-Loyola F, Ballesta-Ors J, Gill N, Caballero A, Pagola J, Pedrote A, Munoz MA, Montaner J. N-Terminal Pro B-Type Natriuretic Peptide's Usefulness for Paroxysmal Atrial Fibrillation Detection Among Populations Carrying Cardiovascular Risk Factors. Front Neurol. 2019 Nov 29;10:1226. doi: 10.3389/fneur.2019.01226. eCollection 2019.

    PubMed 31849809

Questions about this trial

What is this clinical trial studying?

An observational study of Arrhythmia Atrial and Atrial Fibrillation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 11 Apr 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Atrial fibrillation (AF) diagnosis (time frame: Study visit/1 month monitoring). 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 NCT03188484, which also lists 5 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 11 Apr 2022.

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