NCT02789943

Brief Summary

Integrated and cross-disciplinary analysis of human physiology and disease provides unbiased and deeply informative insights into human health and disease. In this study the investigators will recruit patients undergoing coronary artery bypass surgery to study the atrium of the heart or the aortic wall that when diseased can cause strokes. Hypothesis: Systems-level analysis of the left atrium and aorta cells that integrates imaging, histological, cellular and molecular data will identify new mechanism for cardiovascular form and function.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 6, 2017

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

May 30, 2016

Last Update Submit

April 5, 2017

Conditions

Keywords

IHD Normal EF

Outcome Measures

Primary Outcomes (1)

  • First occurrence of cardiovascular event

    One year

Interventions

elective cardiac bypass surgery during which a sample of right atrial appendage and/ or aortic button can be removed

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from wards or referral from clinics at the National Heart Centre Singapore if criteria is fulfil

You may qualify if:

  • Patients undergoing elective cardiac bypass surgery during which a sample of right atrial appendage and/or aortic button can be removed.

You may not qualify if:

  • Infection within 2 weeks preceding the operation or immunosuppressive therapy.
  • Patients not able or willing to consent for study.
  • Previous atrial intervention.
  • Patients who cannot be followed up.
  • Exclude patients with significant valvular disease (any planned valvular surgery, MR \> severe, AS \> severe, TR \> severe).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre

Singapore, Singapore, Singapore

RECRUITING

Related Publications (18)

  • Hogue CW Jr, Creswell LL, Gutterman DD, Fleisher LA; American College of Chest Physicians. Epidemiology, mechanisms, and risks: American College of Chest Physicians guidelines for the prevention and management of postoperative atrial fibrillation after cardiac surgery. Chest. 2005 Aug;128(2 Suppl):9S-16S. doi: 10.1378/chest.128.2_suppl.9s.

    PMID: 16167659BACKGROUND
  • Chew JT, Ong KK. Atrial arrhythmias post coronary bypass grafting. Singapore Med J. 1993 Oct;34(5):430-4.

    PMID: 8153692BACKGROUND
  • Alexander KP, Peterson ED. Coronary artery bypass grafting in the elderly. Am Heart J. 1997 Nov;134(5 Pt 1):856-64. doi: 10.1016/s0002-8703(97)80008-7. No abstract available.

    PMID: 9398097BACKGROUND
  • Ad N, Snir E, Vidne BA, Golomb E. Histologic atrial myolysis is associated with atrial fibrillation after cardiac operation. Ann Thorac Surg. 2001 Sep;72(3):688-93. doi: 10.1016/s0003-4975(01)02882-x.

    PMID: 11565642BACKGROUND
  • Ak K, Akgun S, Tecimer T, Isbir CS, Civelek A, Tekeli A, Arsan S, Cobanoglu A. Determination of histopathologic risk factors for postoperative atrial fibrillation in cardiac surgery. Ann Thorac Surg. 2005 Jun;79(6):1970-5. doi: 10.1016/j.athoracsur.2004.12.029.

    PMID: 15919294BACKGROUND
  • Goette A, Juenemann G, Peters B, Klein HU, Roessner A, Huth C, Rocken C. Determinants and consequences of atrial fibrosis in patients undergoing open heart surgery. Cardiovasc Res. 2002 May;54(2):390-6. doi: 10.1016/s0008-6363(02)00251-1.

    PMID: 12062343BACKGROUND
  • Serri K, Reant P, Lafitte M, Berhouet M, Le Bouffos V, Roudaut R, Lafitte S. Global and regional myocardial function quantification by two-dimensional strain: application in hypertrophic cardiomyopathy. J Am Coll Cardiol. 2006 Mar 21;47(6):1175-81. doi: 10.1016/j.jacc.2005.10.061. Epub 2006 Feb 23.

    PMID: 16545649BACKGROUND
  • Richand V, Lafitte S, Reant P, Serri K, Lafitte M, Brette S, Kerouani A, Chalabi H, Dos Santos P, Douard H, Roudaut R. An ultrasound speckle tracking (two-dimensional strain) analysis of myocardial deformation in professional soccer players compared with healthy subjects and hypertrophic cardiomyopathy. Am J Cardiol. 2007 Jul 1;100(1):128-32. doi: 10.1016/j.amjcard.2007.02.063. Epub 2007 May 21.

    PMID: 17599454BACKGROUND
  • Weidemann F, Niemann M, Herrmann S, Kung M, Stork S, Waller C, Beer M, Breunig F, Wanner C, Voelker W, Ertl G, Bijnens B, Strotmann JM. A new echocardiographic approach for the detection of non-ischaemic fibrosis in hypertrophic myocardium. Eur Heart J. 2007 Dec;28(24):3020-6. doi: 10.1093/eurheartj/ehm454. Epub 2007 Nov 1.

    PMID: 17981828BACKGROUND
  • Park TH, Nagueh SF, Khoury DS, Kopelen HA, Akrivakis S, Nasser K, Ren G, Frangogiannis NG. Impact of myocardial structure and function postinfarction on diastolic strain measurements: implications for assessment of myocardial viability. Am J Physiol Heart Circ Physiol. 2006 Feb;290(2):H724-31. doi: 10.1152/ajpheart.00714.2005. Epub 2005 Sep 23.

    PMID: 16183729BACKGROUND
  • Verma A, Wazni OM, Marrouche NF, Martin DO, Kilicaslan F, Minor S, Schweikert RA, Saliba W, Cummings J, Burkhardt JD, Bhargava M, Belden WA, Abdul-Karim A, Natale A. Pre-existent left atrial scarring in patients undergoing pulmonary vein antrum isolation: an independent predictor of procedural failure. J Am Coll Cardiol. 2005 Jan 18;45(2):285-92. doi: 10.1016/j.jacc.2004.10.035.

    PMID: 15653029BACKGROUND
  • Hwang HJ, Choi EY, Rhee SJ, Joung B, Lee BH, Lee SH, Kim J, Lee MH, Jang Y, Chung N, Kim SS. Left atrial strain as predictor of successful outcomes in catheter ablation for atrial fibrillation: a two-dimensional myocardial imaging study. J Interv Card Electrophysiol. 2009 Nov;26(2):127-32. doi: 10.1007/s10840-009-9410-y. Epub 2009 Jun 16.

    PMID: 19529886BACKGROUND
  • Di Salvo G, Caso P, Lo Piccolo R, Fusco A, Martiniello AR, Russo MG, D'Onofrio A, Severino S, Calabro P, Pacileo G, Mininni N, Calabro R. Atrial myocardial deformation properties predict maintenance of sinus rhythm after external cardioversion of recent-onset lone atrial fibrillation: a color Doppler myocardial imaging and transthoracic and transesophageal echocardiographic study. Circulation. 2005 Jul 19;112(3):387-95. doi: 10.1161/CIRCULATIONAHA.104.463125. Epub 2005 Jul 8.

    PMID: 16006491BACKGROUND
  • Kuppahally SS, Akoum N, Burgon NS, Badger TJ, Kholmovski EG, Vijayakumar S, Rao SN, Blauer J, Fish EN, Dibella EV, Macleod RS, McGann C, Litwin SE, Marrouche NF. Left atrial strain and strain rate in patients with paroxysmal and persistent atrial fibrillation: relationship to left atrial structural remodeling detected by delayed-enhancement MRI. Circ Cardiovasc Imaging. 2010 May;3(3):231-9. doi: 10.1161/CIRCIMAGING.109.865683. Epub 2010 Feb 4.

    PMID: 20133512BACKGROUND
  • Anne W, Willems R, Roskams T, Sergeant P, Herijgers P, Holemans P, Ector H, Heidbuchel H. Matrix metalloproteinases and atrial remodeling in patients with mitral valve disease and atrial fibrillation. Cardiovasc Res. 2005 Sep 1;67(4):655-66. doi: 10.1016/j.cardiores.2005.04.016.

    PMID: 15913581BACKGROUND
  • Ware JS, Petretto E, Cook SA. Integrative genomics in cardiovascular medicine. Cardiovasc Res. 2013 Mar 15;97(4):623-30. doi: 10.1093/cvr/cvs303. Epub 2012 Sep 27.

    PMID: 23024270BACKGROUND
  • Heinig M, Petretto E, Wallace C, Bottolo L, Rotival M, Lu H, Li Y, Sarwar R, Langley SR, Bauerfeind A, Hummel O, Lee YA, Paskas S, Rintisch C, Saar K, Cooper J, Buchan R, Gray EE, Cyster JG; Cardiogenics Consortium; Erdmann J, Hengstenberg C, Maouche S, Ouwehand WH, Rice CM, Samani NJ, Schunkert H, Goodall AH, Schulz H, Roider HG, Vingron M, Blankenberg S, Munzel T, Zeller T, Szymczak S, Ziegler A, Tiret L, Smyth DJ, Pravenec M, Aitman TJ, Cambien F, Clayton D, Todd JA, Hubner N, Cook SA. A trans-acting locus regulates an anti-viral expression network and type 1 diabetes risk. Nature. 2010 Sep 23;467(7314):460-4. doi: 10.1038/nature09386. Epub 2010 Sep 8.

    PMID: 20827270BACKGROUND
  • Petretto E, Sarwar R, Grieve I, Lu H, Kumaran MK, Muckett PJ, Mangion J, Schroen B, Benson M, Punjabi PP, Prasad SK, Pennell DJ, Kiesewetter C, Tasheva ES, Corpuz LM, Webb MD, Conrad GW, Kurtz TW, Kren V, Fischer J, Hubner N, Pinto YM, Pravenec M, Aitman TJ, Cook SA. Integrated genomic approaches implicate osteoglycin (Ogn) in the regulation of left ventricular mass. Nat Genet. 2008 May;40(5):546-52. doi: 10.1038/ng.134.

    PMID: 18443592BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples ( Atrial Appendage Tissue/ Aortic Button ) Blood Serum

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Stuart Alexander Cook

    National Heart Centre Singapore / Duke NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Hafiz Jamal

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 3, 2016

Study Start

May 1, 2013

Primary Completion

July 1, 2017

Study Completion

April 1, 2021

Last Updated

April 6, 2017

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations