NCT04189497

Brief Summary

The availability of several high-cost strategies for the prevention of cardiovascular morbidity and mortality in patients with established cardiovascular disease highlights the necessity of reliable risk stratification of these patients. Several such prognostic models are available for patients with coronary artery disease; however, for patients with ischemic stroke, the available risk stratification schemes are very few and have several limitations. This study aims to develop a prognostication tool to stratify the risk of cardiovascular outcomes in patients with ischemic stroke. The development of a well-designed prognostication tool for the stratification of cardiovascular risk in patients with ischemic stroke may assist to the identification of the highest-risk patients and hence, provide useful information to clinicians and authoritative bodies when prioritizing high-cost strategies for secondary stroke prevention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 30, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

Same day

First QC Date

November 28, 2019

Last Update Submit

December 5, 2019

Conditions

Keywords

Ischemic StrokeRisk stratificationCardiovascular events

Outcome Measures

Primary Outcomes (1)

  • A well-validated prognostication tool for the stratification of the risk of major adverse cardiovascular events in patients with ischemic stroke regardless of the underlying etiology or the pathophysiologic mechanism of the index stroke

    The primary outcome of the study is to built a prognostication tool, in order to predict which stroke patients are going to have the highest risk of secondary major cardiovascular events

    prognostication tool for major cardiovascular adverse events reported during the follow up period, up to 10 years

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This will be a retrospective analysis in the Athens Stroke Registry, which is a prospective registry of all patients with acute first-ever ischemic stroke admitted between 1993 and 2010 within 24 hours after stroke onset and followed up for up to 10 years.The Athens Stroke Registry has supported many research projects with high-quality publications in high-profile journals, some of them may be found here. We expect that the dataset will include all eligible patients, i.e. approximately 3500 patients with ischemic stroke. The dataset will lock the day before the initiation of the study.

You may qualify if:

  • All patients with acute ischemic stroke registered in the Athens Stroke registry will be included in the analysis regardless of the underlying etiology or pathophysiologic mechanism

You may not qualify if:

  • Patients with intracranial haemorrhage or transient ischemic attack

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Larissa, 41110, Greece

Location

Related Publications (18)

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    PMID: 27682883BACKGROUND
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    PMID: 26641808BACKGROUND
  • Ntaios G, Hart RG. Embolic Stroke. Circulation. 2017 Dec 19;136(25):2403-2405. doi: 10.1161/CIRCULATIONAHA.117.030509. No abstract available.

    PMID: 29255121BACKGROUND
  • Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010 Feb;137(2):263-72. doi: 10.1378/chest.09-1584. Epub 2009 Sep 17.

    PMID: 19762550BACKGROUND
  • Ntaios G, Lip GY, Makaritsis K, Papavasileiou V, Vemmou A, Koroboki E, Savvari P, Manios E, Milionis H, Vemmos K. CHADS(2), CHA(2)S(2)DS(2)-VASc, and long-term stroke outcome in patients without atrial fibrillation. Neurology. 2013 Mar 12;80(11):1009-17. doi: 10.1212/WNL.0b013e318287281b. Epub 2013 Feb 13.

    PMID: 23408865BACKGROUND
  • Ntaios G, Vemmos K, Lip GY, Koroboki E, Manios E, Vemmou A, Rodriguez-Campello A, Cuadrado-Godia E, Giralt-Steinhauer E, Arnao V, Caso V, Paciaroni M, Diez-Tejedor E, Fuentes B, Perez Lucas J, Arauz A, Ameriso SF, Hawkes MA, Pertierra L, Gomez-Schneider M, Bandini F, Chavarria Cano B, Iglesias Mohedano AM, Garcia Pastor A, Gil-Nunez A, Putaala J, Tatlisumak T, Barboza MA, Athanasakis G, Makaritsis K, Papavasileiou V. Risk Stratification for Recurrence and Mortality in Embolic Stroke of Undetermined Source. Stroke. 2016 Sep;47(9):2278-85. doi: 10.1161/STROKEAHA.116.013713. Epub 2016 Aug 9.

    PMID: 27507859BACKGROUND
  • Weimar C, Diener HC, Alberts MJ, Steg PG, Bhatt DL, Wilson PW, Mas JL, Rother J; REduction of Atherothrombosis for Continued Health Registry Investigators. The Essen stroke risk score predicts recurrent cardiovascular events: a validation within the REduction of Atherothrombosis for Continued Health (REACH) registry. Stroke. 2009 Feb;40(2):350-4. doi: 10.1161/STROKEAHA.108.521419. Epub 2008 Nov 20.

    PMID: 19023098BACKGROUND
  • Andersen SD, Gorst-Rasmussen A, Lip GY, Bach FW, Larsen TB. Recurrent Stroke: The Value of the CHA2DS2VASc Score and the Essen Stroke Risk Score in a Nationwide Stroke Cohort. Stroke. 2015 Sep;46(9):2491-7. doi: 10.1161/STROKEAHA.115.009912. Epub 2015 Jul 30.

    PMID: 26304862BACKGROUND
  • Bohula EA, Bonaca MP, Braunwald E, Aylward PE, Corbalan R, De Ferrari GM, He P, Lewis BS, Merlini PA, Murphy SA, Sabatine MS, Scirica BM, Morrow DA. Atherothrombotic Risk Stratification and the Efficacy and Safety of Vorapaxar in Patients With Stable Ischemic Heart Disease and Previous Myocardial Infarction. Circulation. 2016 Jul 26;134(4):304-13. doi: 10.1161/CIRCULATIONAHA.115.019861.

    PMID: 27440003BACKGROUND
  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PMID: 15364185BACKGROUND
  • Teo KK, Dokainish H. The Emerging Epidemic of Cardiovascular Risk Factors and Atherosclerotic Disease in Developing Countries. Can J Cardiol. 2017 Mar;33(3):358-365. doi: 10.1016/j.cjca.2016.12.014. Epub 2016 Dec 24.

    PMID: 28232018BACKGROUND
  • O'Donnell MJ, Chin SL, Rangarajan S, Xavier D, Liu L, Zhang H, Rao-Melacini P, Zhang X, Pais P, Agapay S, Lopez-Jaramillo P, Damasceno A, Langhorne P, McQueen MJ, Rosengren A, Dehghan M, Hankey GJ, Dans AL, Elsayed A, Avezum A, Mondo C, Diener HC, Ryglewicz D, Czlonkowska A, Pogosova N, Weimar C, Iqbal R, Diaz R, Yusoff K, Yusufali A, Oguz A, Wang X, Penaherrera E, Lanas F, Ogah OS, Ogunniyi A, Iversen HK, Malaga G, Rumboldt Z, Oveisgharan S, Al Hussain F, Magazi D, Nilanont Y, Ferguson J, Pare G, Yusuf S; INTERSTROKE investigators. Global and regional effects of potentially modifiable risk factors associated with acute stroke in 32 countries (INTERSTROKE): a case-control study. Lancet. 2016 Aug 20;388(10046):761-75. doi: 10.1016/S0140-6736(16)30506-2. Epub 2016 Jul 16.

    PMID: 27431356BACKGROUND
  • Conroy RM, Pyorala K, Fitzgerald AP, Sans S, Menotti A, De Backer G, De Bacquer D, Ducimetiere P, Jousilahti P, Keil U, Njolstad I, Oganov RG, Thomsen T, Tunstall-Pedoe H, Tverdal A, Wedel H, Whincup P, Wilhelmsen L, Graham IM; SCORE project group. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J. 2003 Jun;24(11):987-1003. doi: 10.1016/s0195-668x(03)00114-3.

    PMID: 12788299BACKGROUND
  • Ridker PM, Buring JE, Rifai N, Cook NR. Development and validation of improved algorithms for the assessment of global cardiovascular risk in women: the Reynolds Risk Score. JAMA. 2007 Feb 14;297(6):611-9. doi: 10.1001/jama.297.6.611.

    PMID: 17299196BACKGROUND
  • Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, May M, Brindle P. Derivation and validation of QRISK, a new cardiovascular disease risk score for the United Kingdom: prospective open cohort study. BMJ. 2007 Jul 21;335(7611):136. doi: 10.1136/bmj.39261.471806.55. Epub 2007 Jul 5.

    PMID: 17615182BACKGROUND
  • Woodward M, Brindle P, Tunstall-Pedoe H; SIGN group on risk estimation. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the Scottish Heart Health Extended Cohort (SHHEC). Heart. 2007 Feb;93(2):172-6. doi: 10.1136/hrt.2006.108167. Epub 2006 Nov 7.

    PMID: 17090561BACKGROUND
  • Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.

MeSH Terms

Conditions

Ischemic StrokeCardiovascular Diseases

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 6, 2019

Study Start

June 30, 2019

Primary Completion

June 30, 2019

Study Completion

November 20, 2019

Last Updated

December 6, 2019

Record last verified: 2019-12

Locations