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Trial record 1 of 1 for:    NCT02334852
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Registry of Atrial Fibrillation and Embolic Risk in Mexico (CARMEN-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02334852
Recruitment Status : Completed
First Posted : January 8, 2015
Last Update Posted : April 11, 2017
Sponsor:
Collaborators:
Bayer
Boehringer Ingelheim
Bristol-Myers Squibb
Pfizer
Medicaweb, S.A.C.V.
Information provided by (Responsible Party):
Registro de Fibrilación Auricular y Riesgo Embólico en México

Tracking Information
First Submitted Date January 6, 2015
First Posted Date January 8, 2015
Last Update Posted Date April 11, 2017
Study Start Date December 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2015)
Oral anticoagulation [ Time Frame: One year ]
To analyze quality of anticoagulation with vitamin K antagonists at baseline (control) and one year.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry of Atrial Fibrillation and Embolic Risk in Mexico
Official Title Registry of Atrial Fibrillation and Embolic Risk in Mexico
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with documented diagnosis of AF in the last six months
Condition Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Márquez MF, Baños-González MA, Guevara-Valdivia ME, Vázquez-Acosta J, de Los Ríos Ibarra MO, Aguilar-Linares JA, Jiménez-Cruz M, Matadamas-Hernández N, Camacho-Casillas R, Magaña-Magaña R, Rojel-Martínez U, Alcocer-Gamba MA, Lara-Vaca S, Rodríguez-Reyes H, Islava-Gálvez MA, Betancourt-Hernández LE, Reyes-Reyes N, Beltrán-Gámez ME, Cantú-Brito C, Baños-Velasco AZ, Del Rivero Morfin PJ, González-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 6, 2015)
1200
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02334852
Other Study ID Numbers CARMEN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Registro de Fibrilación Auricular y Riesgo Embólico en México
Study Sponsor Registro de Fibrilación Auricular y Riesgo Embólico en México
Collaborators
  • Bayer
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Pfizer
  • Medicaweb, S.A.C.V.
Investigators
Principal Investigator: Manlio F Marquez-Murillo, MD Instituto Nacional de Cardiología
PRS Account Registro de Fibrilación Auricular y Riesgo Embólico en México
Verification Date April 2017