Coronary Artery Disease (CAD) in Suppressed HIV-infected

NCT02898896 | Terminated DMC

• 1 other identifier: 9642
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation

Conditions

Virus-HIV

Outcome Measures

Primary Outcomes (1)

• coronary computed tomographic angiography (CCTA)

  Assessment of the prevalence of obstructive coronary artery disease in patients infected with HIV and asymptomatic with a 64-slice CT coronary angiography.

  1 month

Secondary Outcomes (5)

• Lymphocyte immune activation

  1 day

• Lymphocyte immunosenescence

  1 day

• Monocyte subpopulation

  1 day

• Microbial translocation

  1 day

• Inflammation

  1 day

Study Arms (1)

HIV-infected patients

OTHER

HIV-infected patients \>= 45 years with 2 or more CV risk factors currently on ART and HIV-RNA \< 50 copies \>= 12 months (one blip allowed) As part of this research, three additional tubes of blood (EDTA) will be taken from patients (21 mL) during blood tests performed as part of a scheduled consultation for the management of their pathology

Biological: blood test

Interventions

blood test BIOLOGICAL

Additional 21 ml of blood will be collected

HIV-infected patients

Eligibility Criteria

• Age: 48 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected patients \>= 45 years with 2 or more CV risk factors currently on ART HIV-RNA \< 50 copies \>= 12 months (one blip allowed) Asymptomatic regarding cardiac symptoms (chest pain, syncope, dyspnea) Stable ART for more than 6 months

You may not qualify if:

• Previous CV event (MI, stroke, unstable angina, CABG) Atrial fibrillation Chronic kidney disease \[eGFR \< 60ml/min MDRD or CKD-Epi) Unstable liver disease History of IV contrast allergy Chronic inflammatory disorders apart from HIV

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Hospital Universitario La Paz: collaborator
• Hospital Reina Sofia, Murcia: collaborator
• Hospital Vall D' Hebron Barcelon: collaborator
• Patras University Hospital, Patras: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Christina PSOMAS

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: March 1, 2017
• Primary Completion: January 5, 2018
• Study Completion: January 5, 2018
• Last Updated: August 12, 2019

Record last verified: 2019-08

Locations

FR (1)