Terminé

AIDS-Associated Heart Disease -- Incidence and Etiology

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Ce qui est collecté

Collecte de données

Qui peut participer

Infections transmises par le sang+16

+ Maladies génito-urinaires

+ Maladies Génitales

Jusqu'à 100 ans
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Comment se déroule l'étude

Observationnel
Date de début : juillet 1988
Voir le détail du protocole

Résumé

Sponsor principalNational Heart, Lung, and Blood Institute (NHLBI)
Dernière mise à jour : 16 mars 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 juillet 1988

Date à laquelle le premier participant a commencé l'étude.

BACKGROUND: Cardiovascular abnormalities have been reported in Acquired Immunodeficiency Syndrome (AIDS) clinically, echocardiographically and at autopsy. Pericardial effusion, cardiac tamponade, echocardiographic abnormalities and clinical cardiomyopathy with right and left-sided congestive heart failure have all been reported as isolated case reports or in small retrospective series of patients with AIDS who had echocardiograms. The frequency with which abnormalities specifically related to AIDS were found in consecutively studied patients was not known in 1988 when the study began. The etiology of these abnormalities was also unclear. Since HIV infection resulted in profound suppression of T-cell macrophage-mediated immunity in AIDS and since there were significant abnormalities in B-cell lymphocyte function resulting in abnormalities of humoral immunity, there were frequently life threatening superinfections by bacterial, fungal, parasitic, and viral organisms. Some of these, such as herpes simplex, cytomegalovirus, cryptococcosis, toxoplasmosis and histoplasmosis, were known to cause pericarditis and myocarditis in the absence of AIDS so the presence of definite myocardial disease in AIDS did not prove that the disease was due to the HIV organism. Using echocardiography to study cardiac structure and function in a small series of patients with AIDS, abnormalities have been identified in from 25 to 75 percent of patients. All of these studies were retrospective; none was prospective with controls. Furthermore, all types of echocardiographic abnormalities have been described including the presence of pericardial fluid, mitral valve prolapse, chamber size abnormalities, and wall motion abnormalities. Although these abnormalities could have been due to infection with the HIV organism there were many other possible reasons for the echocardiographic abnormalities. Among AIDS patients there was a high incidence of intravenous drug and alcohol abuse, patients in whom cardiac abnormalities were common. Since there were no echocardiographic studies comparing HIV antibody- positive groups of patients to appropriate controls, it was not known whether the high reported incidence of echocardiographic abnormalities was related specifically to the HIV infection, to superinfection with other organisms, or was related to factors other than AIDS. This project was part of an Institute-initiated study on AIDS-Associated Heart Disease in Adults. In September 1987 the concept was approved by the National Heart, Lung, and Blood Advisory Council and a Request for Applications was released. Awards were made in July 1988. DESIGN NARRATIVE: Patients were recruited from the in-patient out-patient clinics and wards of the San Francisco General Hospital and the Moffitt-Long Hospitals. A medical history was obtained and a physical examination conducted which included an electrocardiogram, chest x-rays and Doppler echocardiogram. All studies were repeated every four months for four years in HIV-positive groups. If clinical evidence of cardiac disease appeared, all studies including chest x-ray were repeated at that time. If there was normal systolic function in patients with definite left ventricular failure, a radionuclide angiogram was obtained to further evaluate left ventricular diastolic function. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

NCT00005228
Sponsor principalNational Heart, Lung, and Blood Institute (NHLBI)
Dernière mise à jour : 16 mars 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

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Éligibilité

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Conditions
Critères

Homme

Le sexe biologique des participants éligibles à s'inscrire.

Jusqu'à 100 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Infections transmises par le sangMaladies génito-urinairesMaladies GénitalesMaladies CardiovasculairesMaladies TransmissiblesSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsInfections à RetroviridaeInfections à virus ARNMaladies Sexuellement TransmissiblesMaladies à virus lentMaladies viralesMaladies Sexuellement Transmissibles ViralesInfections à LentivirusSyndrome d'Immunodéficience AcquiseMaladies CardiaquesCardiomyopathiesInfections à VIH

Critères

No eligibility criteria

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