Ischemic Heart DiseaseSTaR-CABGNCT02789943
Multi- Level and Integrated Analysis of Mechanisms Underlying Atrial Dysfunction
An observational study of Ischemic Heart Disease, run by National Heart Centre Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Cardiac Bypass Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- 1 siteSingapore
- Study dates
- May 2013to Apr 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from wards or referral from clinics at the National Heart Centre Singapore if criteria is fulfil
Who may be able to join
- Patients undergoing elective cardiac bypass surgery during which a sample of right atrial appendage and/or aortic button can be removed.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre
Singapore, Singapore
Muhammad Hafiz Jamal, 97547816 ext. +65, muhd.hafiz.jamal@nhcs.com.sg
Stuart Alexander Cook, MBBS,MRCP,PhD
About this study
Official title: The National Heart Centre Singapore Prospective CABG Cohort: Multi- Level and Integrated Analysis of Mechanisms Underlying Atrial Dysfunction
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.
Read the detailed description
While there are many sub-aims to this study, the overarching goal is to define molecular mechanisms underlying atrial dysfunction. Here the investigator provide a power calculation based on detecting the genetic control points of gene expression (eQTLs) in the human atrial fibroblast. The investigator and many others have shown that tissue-specific eQTLs can be robustly identified at genome-wide significance in segregating populations of ~200. In this study the investigator propose eQTL association analysis in humans, which have previously been successfully performed in cohorts of less than 1000 subjects. The general applicability of this approach has been validated in multiple studies across multiple tissues in cohorts of between 200-1000 subjects.Based on published imaging genetic studies that have been successfully applied in small cohorts (<500) and the success of echo-based, semi-quantitative studies of ventricular dimensions, the investigator are confident that our quantitative studies of 750 individuals are powered to detect genome wide significant loci for the traits under study.
Despite intensive research there is a critical gap in our knowledge in the mechanisms underlying atrial fibrillation, which is a major cause of stroke and heart failure and increasingly common as it is a disease of the elderly. This project will address this important gap in our knowledge and provide new insights into disease pathogenesis with the goal of stratifying participants to prevent strokes and for treating the underlying substrate.
- Conditions
- Ischemic Heart Disease
- Being tested
- Cardiac Bypass Surgery
- Keywords
- IHD Normal EF
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Bypass SurgeryProcedure or surgery
elective cardiac bypass surgery during which a sample of right atrial appendage and/ or aortic button can be removed
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of cardiovascular event
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startMay 2013
- Primary completionJul 2017 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Stuart Alexander Cook, Principal investigator, National Heart Centre Singapore / Duke NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789943
- Sponsor's protocol ID
- 2013/103/C
- Acronym
- STaR-CABG
- Status last verified
- May 2016
- First submitted
- 30 May 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 16167659Chew JT, Ong KK. Atrial arrhythmias post coronary bypass grafting. Singapore Med J. 1993 Oct;34(5):430-4.
PubMed 8153692Alexander 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.
PubMed 9398097Ad 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.
PubMed 11565642Ak 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.
PubMed 15919294Goette 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.
PubMed 12062343Serri 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.
PubMed 16545649Richand 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.
PubMed 17599454Weidemann 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.
PubMed 17981828Park 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.
PubMed 16183729Verma 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.
PubMed 15653029Hwang 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.
PubMed 19529886Di 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.
PubMed 16006491Kuppahally 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.
PubMed 20133512Anne 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.
PubMed 15913581
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Heart Centre Singapore Prospective CABG Cohort: Multi- Level and Integrated Analysis of Mechanisms Underlying Atrial Dysfunction
- ClinicalTrials.gov ID
- NCT02789943
- Acronym / sponsor ID
- STaR-CABG / 2013/103/C
- Conditions
- Ischemic Heart Disease
- Keywords
- IHD Normal EF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Study start
- May 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
While there are many sub-aims to this study, the overarching goal is to define molecular mechanisms underlying atrial dysfunction. Here the investigator provide a power calculation based on detecting the genetic control points of gene expression (eQTLs) in the human atrial fibroblast. The investigator and many others have shown that tissue-specific eQTLs can be robustly identified at genome-wide significance in segregating populations of ~200. In this study the investigator propose eQTL association analysis in humans, which have previously been successfully performed in cohorts of less than 1000 subjects. The general applicability of this approach has been validated in multiple studies across multiple tissues in cohorts of between 200-1000 subjects.Based on published imaging genetic studies that have been successfully applied in small cohorts (<500) and the success of echo-based, semi-quantitative studies of ventricular dimensions, the investigator are confident that our quantitative studies of 750 individuals are powered to detect genome wide significant loci for the traits under study.
Despite intensive research there is a critical gap in our knowledge in the mechanisms underlying atrial fibrillation, which is a major cause of stroke and heart failure and increasingly common as it is a disease of the elderly. This project will address this important gap in our knowledge and provide new insights into disease pathogenesis with the goal of stratifying participants to prevent strokes and for treating the underlying substrate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from wards or referral from clinics at the National Heart Centre Singapore if criteria is fulfil
Key inclusion criteria (1 listed)
- Patients undergoing elective cardiac bypass surgery during which a sample of right atrial appendage and/or aortic button can be removed.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Bypass Surgeryelective cardiac bypass surgery during which a sample of right atrial appendage and/ or aortic button can be removed | Procedure or surgery | – |
Primary outcome
First occurrence of cardiovascular event
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Background: PubMed 16167659Hogue 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.
- Background: PubMed 8153692Chew JT, Ong KK. Atrial arrhythmias post coronary bypass grafting. Singapore Med J. 1993 Oct;34(5):430-4.
- Background: PubMed 9398097Alexander 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.
- Background: PubMed 11565642Ad 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.
- Background: PubMed 15919294Ak 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.
- Background: PubMed 12062343Goette 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.
- Background: PubMed 16545649Serri 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.
- Background: PubMed 17599454Richand 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.
- Background: PubMed 17981828Weidemann 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.
- Background: PubMed 16183729Park 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.
- Background: PubMed 15653029Verma 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.
- Background: PubMed 19529886Hwang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Alexander Cook principal investigator
National Heart Centre Singapore / Duke NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by National Heart Centre Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Hafiz Jamal (97547816 / ext. +65, muhd.hafiz.jamal@nhcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First occurrence of cardiovascular event (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789943, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017; AzTrials last refreshed its copy on 5 Nov 2026.