Registry of Atrial Fibrillation and Embolic Risk in Mexico

NCT02334852 | Completed

• 1 other identifier: CARMEN
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Oral anticoagulation

  To analyze quality of anticoagulation with vitamin K antagonists at baseline (control) and one year.

  One year

Eligibility Criteria

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

Study Population

Patients with documented diagnosis of AF in the last six months

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Registro de Fibrilación Auricular y Riesgo Embólico en México: lead
• Bayer: collaborator
• Boehringer Ingelheim: collaborator
• Bristol-Myers Squibb: collaborator
• Pfizer: collaborator
• Medicaweb, S.A.C.V.: collaborator

Related Publications (1)

• 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.

  PMID: 32489805 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manlio F Marquez-Murillo, MD

  Instituto Nacional de Cardiología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04