NCT06194409

Brief Summary

We aim to describe the incidence of IVDA among patients presented with IE, describe their clinical, psychiatric and microbiological characteristics in comparison to non - IVDA, as well as the rate and types of complications and outcome, and responsiveness to medical treatment or surgical intervention.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

October 2, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

October 2, 2023

Last Update Submit

June 23, 2024

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (2)

  • The incidence of IVDA among IE patients

    Report the incidence of IVDA among IE patients, describe their clinical and microbiological characteristics comparison to the IE in non - IVDA.

    Baseline

  • The complications of IVDA among IE patients

    Report the rates and types of complications

    Baseline

Secondary Outcomes (4)

  • The psychiatric characteristics of the addict group

    Baseline

  • The Withdrawal symptoms of the study group

    Baseline

  • The psychiatric characteristics of the study group

    Baseline

  • The personality characteristics of the study group

    Baseline

Study Arms (2)

IE in IV drug abusers

Infective endocarditis in intravenous drug abusers

Diagnostic Test: Echocardiography, Urine analysis , blood culture

IE in non- IV drug abusers

Infective endocarditis in non - intravenous drug abusers

Diagnostic Test: Echocardiography, Urine analysis , blood culture

Interventions

Echocardiography, Urine analysis , blood cultureDIAGNOSTIC_TEST

All patients will be investigated by ECG, Urine analysis, blood culture , Echocardiography

IE in IV drug abusersIE in non- IV drug abusers

Eligibility Criteria

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

Patients admitted to Assiut University Heart Hospital with definite or possible Infective endocarditis

You may qualify if:

  • Adult Patients (\>18 years) with definite or possible IE.

You may not qualify if:

  • Patients with rejected diagnosis of infective endocarditis after workup, according to modified Duke's criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

Related Publications (11)

  • Math RS, Sharma G, Kothari SS, Kalaivani M, Saxena A, Kumar AS, Bahl VK. Prospective study of infective endocarditis from a developing country. Am Heart J. 2011 Oct;162(4):633-8. doi: 10.1016/j.ahj.2011.07.014. Epub 2011 Sep 14.

    PMID: 21982654BACKGROUND

  • Noubiap JJ, Nkeck JR, Kwondom BS, Nyaga UF. Epidemiology of infective endocarditis in Africa: a systematic review and meta-analysis. Lancet Glob Health. 2022 Jan;10(1):e77-e86. doi: 10.1016/S2214-109X(21)00400-9.

    PMID: 34919859BACKGROUND

  • Bor DH, Woolhandler S, Nardin R, Brusch J, Himmelstein DU. Infective endocarditis in the U.S., 1998-2009: a nationwide study. PLoS One. 2013;8(3):e60033. doi: 10.1371/journal.pone.0060033. Epub 2013 Mar 20.

    PMID: 23527296BACKGROUND

  • Schranz AJ, Fleischauer A, Chu VH, Wu LT, Rosen DL. Trends in Drug Use-Associated Infective Endocarditis and Heart Valve Surgery, 2007 to 2017: A Study of Statewide Discharge Data. Ann Intern Med. 2019 Jan 1;170(1):31-40. doi: 10.7326/M18-2124. Epub 2018 Dec 4.

    PMID: 30508432BACKGROUND

  • Delgado V, Ajmone Marsan N, de Waha S, Bonaros N, Brida M, Burri H, Caselli S, Doenst T, Ederhy S, Erba PA, Foldager D, Fosbol EL, Kovac J, Mestres CA, Miller OI, Miro JM, Pazdernik M, Pizzi MN, Quintana E, Rasmussen TB, Ristic AD, Rodes-Cabau J, Sionis A, Zuhlke LJ, Borger MA; ESC Scientific Document Group. 2023 ESC Guidelines for the management of endocarditis. Eur Heart J. 2023 Oct 14;44(39):3948-4042. doi: 10.1093/eurheartj/ehad193. No abstract available.

    PMID: 37622656BACKGROUND

  • Scheggi V, Del Pace S, Ceschia N, Vanni F, Merilli I, Sottili E, Salcuni L, Zoppetti N, Alterini B, Cerillo A, Marchionni N, Stefano PL. Infective endocarditis in intravenous drug abusers: clinical challenges emerging from a single-centre experience. BMC Infect Dis. 2021 Sep 27;21(1):1010. doi: 10.1186/s12879-021-06697-1.

    PMID: 34579674BACKGROUND

  • Goyal A, Mohan B, Kumar P, Gupta D, Tandon R, Singla S, Singh G, Singh B, Chhabra ST, Aslam N, Wander GS. Clinical characteristics and outcome of infective endocarditis among intravenous drug abusers in India. Indian Heart J. 2020 Nov-Dec;72(6):547-551. doi: 10.1016/j.ihj.2020.09.014. Epub 2020 Sep 18.

    PMID: 33357643BACKGROUND

  • McLellan AT, Luborsky L, Woody GE, O'Brien CP. An improved diagnostic evaluation instrument for substance abuse patients. The Addiction Severity Index. J Nerv Ment Dis. 1980 Jan;168(1):26-33. doi: 10.1097/00005053-198001000-00006.

    PMID: 7351540BACKGROUND

  • Derogatis, L.R. and Savitz, K.L. (2000) The SCL-90-R and the Brief Symptom Inventory (BSI) in Primary Care. In:: Maruish, M.E., Ed., Handbook of Psychological Assessment in Primary Care Settings, Vol. 236, Lawrence Erlbaum Associates, Mahwah, 297-334

    BACKGROUND

  • Hans Jürgen Eysenck & Sybil B. G. Eysenck (1975). Manual of the Eysenck Personality Questionnaire, London: Hodder and Stoughton

    BACKGROUND

  • Macingwane J., Ngwenya B.N. Identification of active compounds of Albizia lebbeck against HIV-1 reverse transcriptase: a computational study. J. Biomol. Struct. Dyn. 2021;39(14):5300-5311. [Google Scholar]

    BACKGROUND

MeSH Terms

Conditions

Endocarditis

Interventions

EchocardiographyUrinalysisBlood Culture

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques, UrologicalInvestigative TechniquesMicrobiological Techniques

Study Officials

  • Yehia Kish

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Peter Alaa

CONTACT

01026654536peteralaa391@gmail.com

Shimaa Sayed

CONTACT

+20 100 134 6551shaimaakhidr@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at cardiology department, Faculty of medicine, Assiut University

Study Record Dates

First Submitted

October 2, 2023

First Posted

January 8, 2024

Study Start

May 5, 2024

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations

EG(1)