Clinical trial NCT02334852: Registry of Atrial Fibrillation and Embolic Risk in Mexico
Official title: Registry of Atrial Fibrillation and Embolic Risk in Mexico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Registro de Fibrilación Auricular y Riesgo Embólico en México
Sponsor class: OTHER
Collaborators: name: Bayer
name: Boehringer Ingelheim
name: Bristol-Myers Squibb
name: Pfizer
name: Medicaweb, S.A.C.V.
First posted: 2015-01-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with documented diagnosis of AF in the last six months

Brief summary: The AF is the most common arrhythmia in clinical practice affecting 1-2% of the general population. It is the most common cause of cerebrovascular events (CVE), responsible for 25% of all ischemic strokes and 50% of cardioembolic strokes.

The CARMEN-AF registry is planned to be the first registry of non-valvular AF in Mexico with national representation, planning and specific objectives for publications. Follow-up period of two years is planned.

Detailed description: The CARMEN-AF registry intends to achieve a national sample of non-valvular AF in male and female patients older than 18 years through the participation of every state of Mexico. Thus, a wide geographical distribution will allow comparing health care quality between different geographical areas in which the patients are attended (Northwest, North, Center, Mexico City, East and Southeast).

Besides, to guarantee this national representation, the principle health institutions are planned to participate, the public and the private ones.

Primary objectives:

To know the current state of thromboprophylaxis in non-valvular Atrial Fibrillation (AF) in Mexico.

To evaluate the therapeutic behavior according to the Clinical Practice Guidelines (CPG) at baseline and one year follow-up, with an educational strategy to increase the adherence.

Secondary objectives:

To identify the characteristics of oral anticoagulants current use in Mexico.

To analyze the efficiency of anticoagulation with vitamin K antagonists and the new oral anticoagulants, at baseline and one year follow-up.

Descriptive statistics:

For each group of variables the following descriptive statistics will be obtained:

In continuous variables: mean, standard deviation (SD), standard error, confidence interval (CI) 95%, minimum, percentile 25, median, percentile75, maximum, n and number of lost data.

In categorical variables: % from total column, n in each category. Lost data will be treated as a new category.

Ethical aspects:

Every investigator should fulfil the study according with the principles of the Helsinki declaration.

Copies of the Helsinki Declaration and its subsequent amendments will be provided under specific request or can be obtained through the World Medical Association website (http://www.wma.net/en/30publications /10policies/b3/index.html).

The study should be developed in accordance with the protocol and the procedures that ensure the standards of Good Clinical Practice (GCP) compliance (1996).

The study will be conducted in accordance with the guidelines for Good Epidemiological Practice.

Risk-benefit assessment for the research subjects:

Patients included in the study are not subject to experimental considerations.

Information sheet and informed consent form:

As this study represents a longitudinal observational registry that does not imply therapeutic change, no informed consent form is contemplated.

Eligibility criteria: Inclusion Criteria:

* Patients with documented diagnosis of AF in the last six months by 12-lead electrocardiogram, rhythm strip, or Holter monitoring, pacemaker minimum 30 seconds (with or without treatment and regardless of rhythm during enrollment)
* Patients presenting AF (diagnosed by standard ECG or Holter monitoring) at baseline
* Patients should be eligible for treatment with oral anticoagulant thromboprophylaxis
* Patients with at least 1 risk factor for thromboembolism (CVE or outside the CNS) according to CHA2DS2VASc

Exclusion Criteria:

* AF of transient causes (thyrotoxicosis, alcohol intoxication, myocardial infarction (MI) acute phase, pericarditis, myocarditis, electrocution, pulmonary embolism or other lung disease, electrolyte or metabolic disorder,etc).
* AF onset in immediate postoperative or 3 months in cardiac surgery
* Terminal illness
* Mental Inability to take anticoagulants
* Inability to fulfill the follow-up visits
* Programming for ablation of pulmonary veins
* Pregnant or lactating women

Primary outcomes:
measure: Oral anticoagulation
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Cardiología
name: Manlio F Marquez-Murillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marquez MF, Banos-Gonzalez MA, Guevara-Valdivia ME, Vazquez-Acosta J, de Los Rios Ibarra MO, Aguilar-Linares JA, Jimenez-Cruz M, Matadamas-Hernandez N, Camacho-Casillas R, Magana-Magana R, Rojel-Martinez U, Alcocer-Gamba MA, Lara-Vaca S, Rodriguez-Reyes H, Islava-Galvez MA, Betancourt-Hernandez LE, Reyes-Reyes N, Beltran-Gamez ME, Cantu-Brito C, Banos-Velasco AZ, Del Rivero Morfin PJ, Gonzalez-Hermosillo JA. Anticoagulation Therapy by Age and Embolic Risk for Nonvalvular Atrial Fibrillation in Mexico, an Upper-Middle-Income Country: The CARMEN-AF Registry. Glob Heart. 2020 Apr 10;15(1):32. doi: 10.5334/gh.767.