Qatar Cardiovascular Biorepository of AF Patients

NCT03660696 | Unknown

• 1 other identifier: MRC-01-17-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Qatar Cardiovascular Biorepsoitory-AF (QCBio-AF) of plasma and DNA of Qatari patients with atrial fibrillation (AF) is to establish. AF cases will include patients with acute and chronic AF identified in the Heart Hospital (HH) arrhythmia clinics and Emergency Room (ER). Controls will include blood donors who have no history of AF. Such a resource will enable validation of biomarkers to assess AF risk, response to therapy, and prognosis. QCBio-AF will also allow genomic, marker and proteomic studies of AF and response to drug therapy (pharmacogenetics and pharmacoproteomics). This study will accomplish the following specific aims: Aim 1: Establish a DNA and plasma biorepository (QCBio-AF) of 300 Qatari AF cases and Family members to enable investigation of genomic and proteomic biomarkers for early detection and prognostication and to identify new targets for drug development. Aim 2: Annotate the biorepository of with 1) demographic, laboratory, and clinical variables derived from the EMR using electronic phenotyping algorithms, and 2) detailed information regarding history of cardiovascular diseases and risk factors derived from patient surveys. Aim 3: Develop processes to promote use of the biorepository by Qatari investigators by facilitating access to the biorepository for biomarker research, while maintaining the highest ethical standards with emphasis on patient confidentiality and stewardship of the biospecimens. Timeline. Following IRB approval, the intended collection period will be over 12 months where 300 Qatari patients with AF and their immediate families will be recruited. Significance: Although atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European populations, the worldwide burden of AF in non-white populations is unknown. Furthermore, a substantial proportion of AF in the population is not explained by traditional risk factors. There is increasing evidence that susceptibility to AF is not only determined by underlying etiologic risk factors but also ethnicity with AF occurring more frequently in white than in non-white populations. While reasons for this ethnic variability are unknown, studies have shown that both common and rare genetic variants increase susceptibility to AF in an individual in the presence of ethnic-specific risk factors.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of KCNQ1 Gene expression in AF

  Establish a DNA and plasma biorepository (QCBio-AF) of 300 Qatari AF cases and Family members to enable investigation of genomic and proteomic biomarkers for early detection and prognostication and to identify new targets for drug development

  One year

• Incidence of AF in diverse ethnic population

  Risk factors for AF in diverse ethnic population

  One year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Qatari subjects must have a documented history of AF or atrial flutter by ECG, ECHO, and or Holter monitor event recorder. Subjects' family members approached for the study may or may not have a documented history AF.

You may qualify if:

• Age \>=18 years
• History of AF and without
• Atrial flutter by ECG, ECHO or Holter monitor event recorder
• Willing to give written informed consent.

You may not qualify if:

• AF or atrial flutter associated with cardiac surgery
• Pregnant females (at the baseline visit) and prisoners.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Heart Hospital, Hamad Medical Coorporation

Doha, 3050, Qatar

Location

Related Publications (9)

• Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.

  PMID: 24345399 RESULT

• Stewart S, Murphy NF, Walker A, McGuire A, McMurray JJ. Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart. 2004 Mar;90(3):286-92. doi: 10.1136/hrt.2002.008748.

  PMID: 14966048 RESULT

• Bruggenjurgen B, Rossnagel K, Roll S, Andersson FL, Selim D, Muller-Nordhorn J, Nolte CH, Jungehulsing GJ, Villringer A, Willich SN. The impact of atrial fibrillation on the cost of stroke: the berlin acute stroke study. Value Health. 2007 Mar-Apr;10(2):137-43. doi: 10.1111/j.1524-4733.2006.00160.x.

  PMID: 17391422 RESULT

• Fox CS, Parise H, D'Agostino RB Sr, Lloyd-Jones DM, Vasan RS, Wang TJ, Levy D, Wolf PA, Benjamin EJ. Parental atrial fibrillation as a risk factor for atrial fibrillation in offspring. JAMA. 2004 Jun 16;291(23):2851-5. doi: 10.1001/jama.291.23.2851.

  PMID: 15199036 RESULT

• Arnar DO, Thorvaldsson S, Manolio TA, Thorgeirsson G, Kristjansson K, Hakonarson H, Stefansson K. Familial aggregation of atrial fibrillation in Iceland. Eur Heart J. 2006 Mar;27(6):708-12. doi: 10.1093/eurheartj/ehi727. Epub 2006 Jan 20.

  PMID: 16428254 RESULT

• Christophersen IE, Ravn LS, Budtz-Joergensen E, Skytthe A, Haunsoe S, Svendsen JH, Christensen K. Familial aggregation of atrial fibrillation: a study in Danish twins. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):378-83. doi: 10.1161/CIRCEP.108.786665. Epub 2009 Apr 23.

  PMID: 19808493 RESULT

• Salam AM, AlBinali HA, Al-Mulla AW, Singh R, Al Suwaidi J. Secular trends, treatments, and outcomes of Middle Eastern Arab and South Asian patients hospitalized with atrial fibrillation: insights from a 20-year registry in Qatar (1991-2010). Angiology. 2013 Oct;64(7):498-504. doi: 10.1177/0003319712460332. Epub 2012 Oct 1.

  PMID: 23028177 RESULT

• Salam AM, AlBinali HA, Al-Mulla AW, Asaad N, Singh R, Al-Qahtani A, Al Suwaidi J. Women hospitalized with atrial fibrillation: gender differences, trends and outcome from a 20-year registry in a Middle Eastern country (1991-2010). Int J Cardiol. 2013 Sep 30;168(2):975-80. doi: 10.1016/j.ijcard.2012.10.041. Epub 2012 Nov 15.

  PMID: 23159409 RESULT

• Salam AM, AlBinali HA, Al-Sulaiti EM, Al-Mulla AW, Singh R, Al Suwaidi J. Effect of age on treatment, trends and outcome of patients hospitalized with atrial fibrillation: insights from a 20-years registry in a Middle-Eastern country (1991-2010). Aging Clin Exp Res. 2012 Dec;24(6):682-90. doi: 10.3275/8757. Epub 2012 Nov 26.

  PMID: 23211770 RESULT

Biospecimen

Retention: NONE RETAINED

patients and family members with AF to enable subsequent clinical, molecular, and genetic studies. We outline here the rationale for studies that will utilize this resource, as well as specific hypotheses that will be evaluated and approaches that will be undertaken

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nidal Asaad, MD

CONTACT

44805261; nasaad@hamad.qa

Rajvir Singh, PhD

CONTACT

55897044; rajvir.aiims@gmail.com

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: September 6, 2018
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 3, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)