Treatment of Periodontal Disease in Patients With Acute Myocardial Infarction
TPAMI
1 other identifier
interventional
54
1 country
1
Brief Summary
The main objective of this study is to evaluate the effect of treatment periodontal endothelium-dependent artery of the arm in patients with acute myocardial infarction with ST-segment elevation undergoing primary coronary intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2012
Typical duration for not_applicable
1 active site
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
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedSeptember 7, 2015
September 1, 2015
2.4 years
August 27, 2015
September 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The difference in dilation measured by brachial artery blood flow
The primary outcome will be the difference in the dilation measured through the flow in the brachial artery by the end of six months.
6 months
Secondary Outcomes (1)
Major cardiovascular events
6 months
Other Outcomes (1)
Bacteremia
24 hours
Study Arms (2)
periodontal treatment
EXPERIMENTALGroup will receive treatment: periodontal treatment
Control Group.
NO INTERVENTIONGroup will not receive treatment: periodontal treatment
Interventions
Eligibility Criteria
You may qualify if:
- patients admitted to our institution with a diagnosis of AMI (ST segment elevation\> 0.1mV)
- older than 30 years
- with more than 8 teeth in the mouth
- with advanced periodontal disease
You may not qualify if:
- acute or chronical infection
- impossibility of attending the following interviews and/or the periodontal treatment
- refusing to signing the consent form
- individuals with substance abuse
- anticonvulsants and immunosuppressant drugs users
- pregnant and \\ or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (29)
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PMID: 21561658BACKGROUNDBahekar AA, Singh S, Saha S, Molnar J, Arora R. The prevalence and incidence of coronary heart disease is significantly increased in periodontitis: a meta-analysis. Am Heart J. 2007 Nov;154(5):830-7. doi: 10.1016/j.ahj.2007.06.037. Epub 2007 Aug 20.
PMID: 17967586BACKGROUNDD'Aiuto F, Parkar M, Tonetti MS. Acute effects of periodontal therapy on bio-markers of vascular health. J Clin Periodontol. 2007 Feb;34(2):124-9. doi: 10.1111/j.1600-051X.2006.01037.x. Epub 2007 Jan 3.
PMID: 17214734BACKGROUNDHumphrey LL, Fu R, Buckley DI, Freeman M, Helfand M. Periodontal disease and coronary heart disease incidence: a systematic review and meta-analysis. J Gen Intern Med. 2008 Dec;23(12):2079-86. doi: 10.1007/s11606-008-0787-6. Epub 2008 Sep 20.
PMID: 18807098BACKGROUNDLibby P, Ridker PM, Hansson GK; Leducq Transatlantic Network on Atherothrombosis. Inflammation in atherosclerosis: from pathophysiology to practice. J Am Coll Cardiol. 2009 Dec 1;54(23):2129-38. doi: 10.1016/j.jacc.2009.09.009.
PMID: 19942084BACKGROUNDLockhart PB, Bolger AF, Papapanou PN, Osinbowale O, Trevisan M, Levison ME, Taubert KA, Newburger JW, Gornik HL, Gewitz MH, Wilson WR, Smith SC Jr, Baddour LM; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee of the Council on Cardiovascular Disease in the Young, Council on Epidemiology and Prevention, Council on Peripheral Vascular Disease, and Council on Clinical Cardiology. Periodontal disease and atherosclerotic vascular disease: does the evidence support an independent association?: a scientific statement from the American Heart Association. Circulation. 2012 May 22;125(20):2520-44. doi: 10.1161/CIR.0b013e31825719f3. Epub 2012 Apr 18.
PMID: 22514251BACKGROUNDRidker PM. C-reactive protein, inflammation, and cardiovascular disease: clinical update. Tex Heart Inst J. 2005;32(3):384-6. No abstract available.
PMID: 16392225BACKGROUNDTonetti MS, D'Aiuto F, Nibali L, Donald A, Storry C, Parkar M, Suvan J, Hingorani AD, Vallance P, Deanfield J. Treatment of periodontitis and endothelial function. N Engl J Med. 2007 Mar 1;356(9):911-20. doi: 10.1056/NEJMoa063186.
PMID: 17329698BACKGROUNDYu YH, Chasman DI, Buring JE, Rose L, Ridker PM. Cardiovascular risks associated with incident and prevalent periodontal disease. J Clin Periodontol. 2015 Jan;42(1):21-8. doi: 10.1111/jcpe.12335. Epub 2015 Jan 9.
PMID: 25385537BACKGROUNDAlbandar JM, Brunelle JA, Kingman A. Destructive periodontal disease in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):13-29. doi: 10.1902/jop.1999.70.1.13.
PMID: 10052767BACKGROUNDCastro GD, Oppermann RV, Haas AN, Winter R, Alchieri JC. Association between psychosocial factors and periodontitis: a case-control study. J Clin Periodontol. 2006 Feb;33(2):109-14. doi: 10.1111/j.1600-051X.2005.00878.x.
PMID: 16441734BACKGROUNDD'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60. doi: 10.1177/154405910408300214.
PMID: 14742655BACKGROUNDD'Aiuto F, Parkar M, Tonetti MS. Periodontal therapy: a novel acute inflammatory model. Inflamm Res. 2005 Oct;54(10):412-4. doi: 10.1007/s00011-005-1375-4.
PMID: 16283108BACKGROUNDElter JR, Hinderliter AL, Offenbacher S, Beck JD, Caughey M, Brodala N, Madianos PN. The effects of periodontal therapy on vascular endothelial function: a pilot trial. Am Heart J. 2006 Jan;151(1):47. doi: 10.1016/j.ahj.2005.10.002.
PMID: 16368290BACKGROUNDJoshipura KJ, Wand HC, Merchant AT, Rimm EB. Periodontal disease and biomarkers related to cardiovascular disease. J Dent Res. 2004 Feb;83(2):151-5. doi: 10.1177/154405910408300213.
PMID: 14742654BACKGROUNDLibby P, Okamoto Y, Rocha VZ, Folco E. Inflammation in atherosclerosis: transition from theory to practice. Circ J. 2010 Feb;74(2):213-20. doi: 10.1253/circj.cj-09-0706. Epub 2010 Jan 9.
PMID: 20065609BACKGROUNDPussinen PJ, Tuomisto K, Jousilahti P, Havulinna AS, Sundvall J, Salomaa V. Endotoxemia, immune response to periodontal pathogens, and systemic inflammation associate with incident cardiovascular disease events. Arterioscler Thromb Vasc Biol. 2007 Jun;27(6):1433-9. doi: 10.1161/ATVBAHA.106.138743. Epub 2007 Mar 15.
PMID: 17363692BACKGROUNDRamirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.
PMID: 21324167BACKGROUNDTeeuw WJ, Slot DE, Susanto H, Gerdes VE, Abbas F, D'Aiuto F, Kastelein JJ, Loos BG. Treatment of periodontitis improves the atherosclerotic profile: a systematic review and meta-analysis. J Clin Periodontol. 2014 Jan;41(1):70-9. doi: 10.1111/jcpe.12171. Epub 2013 Oct 29.
PMID: 24111886BACKGROUNDBlum A, Front E, Peleg A. Periodontal care may improve systemic inflammation. Clin Invest Med. 2007;30(3):E114-7. doi: 10.25011/cim.v30i3.1079.
PMID: 17716549BACKGROUNDPischon N, Hagewald S, Kunze M, Heng N, Christan C, Kleber BM, Muller C, Bernimoulin JP. Influence of periodontal therapy on the regulation of soluble cell adhesion molecule expression in aggressive periodontitis patients. J Periodontol. 2007 Apr;78(4):683-90. doi: 10.1902/jop.2007.060286.
PMID: 17397316BACKGROUNDLi X, Tse HF, Jin LJ. Novel endothelial biomarkers: implications for periodontal disease and CVD. J Dent Res. 2011 Sep;90(9):1062-9. doi: 10.1177/0022034510397194. Epub 2011 Feb 14.
PMID: 21321068BACKGROUNDLi X, Tse HF, Yiu KH, Li LS, Jin L. Effect of periodontal treatment on circulating CD34(+) cells and peripheral vascular endothelial function: a randomized controlled trial. J Clin Periodontol. 2011 Feb;38(2):148-56. doi: 10.1111/j.1600-051X.2010.01651.x. Epub 2010 Dec 6.
PMID: 21133981BACKGROUNDPiconi S, Trabattoni D, Luraghi C, Perilli E, Borelli M, Pacei M, Rizzardini G, Lattuada A, Bray DH, Catalano M, Sparaco A, Clerici M. Treatment of periodontal disease results in improvements in endothelial dysfunction and reduction of the carotid intima-media thickness. FASEB J. 2009 Apr;23(4):1196-204. doi: 10.1096/fj.08-119578. Epub 2008 Dec 12.
PMID: 19074511BACKGROUNDAmar S, Gokce N, Morgan S, Loukideli M, Van Dyke TE, Vita JA. Periodontal disease is associated with brachial artery endothelial dysfunction and systemic inflammation. Arterioscler Thromb Vasc Biol. 2003 Jul 1;23(7):1245-9. doi: 10.1161/01.ATV.0000078603.90302.4A. Epub 2003 May 22.
PMID: 12763762BACKGROUNDMercanoglu F, Oflaz H, Oz O, Gokbuget AY, Genchellac H, Sezer M, Nisanci Y, Umman S. Endothelial dysfunction in patients with chronic periodontitis and its improvement after initial periodontal therapy. J Periodontol. 2004 Dec;75(12):1694-700. doi: 10.1902/jop.2004.75.12.1694.
PMID: 15732873BACKGROUNDSaffi MA, Furtado MV, Polanczyk CA, Montenegro MM, Ribeiro IW, Kampits C, Haas AN, Rosing CK, Rabelo-Silva ER. Relationship between vascular endothelium and periodontal disease in atherosclerotic lesions: Review article. World J Cardiol. 2015 Jan 26;7(1):26-30. doi: 10.4330/wjc.v7.i1.26.
PMID: 25632316BACKGROUNDSeinost G, Wimmer G, Skerget M, Thaller E, Brodmann M, Gasser R, Bratschko RO, Pilger E. Periodontal treatment improves endothelial dysfunction in patients with severe periodontitis. Am Heart J. 2005 Jun;149(6):1050-4. doi: 10.1016/j.ahj.2004.09.059.
PMID: 15976787BACKGROUNDLobo MG, Schmidt MM, Lopes RD, Dipp T, Feijo IP, Schmidt KES, Gazeta CA, Azeredo ML, Markoski M, Pellanda LC, Gottschall CAM, Quadros AS. Treating periodontal disease in patients with myocardial infarction: A randomized clinical trial. Eur J Intern Med. 2020 Jan;71:76-80. doi: 10.1016/j.ejim.2019.08.012. Epub 2019 Dec 4.
PMID: 31810741DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Sc Quadros, Phd
Instituto de Cardiologia do Rio Grande do Sul, IC-FUC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2015
First Posted
September 7, 2015
Study Start
August 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
September 7, 2015
Record last verified: 2015-09