Ignite Creation Date:
2024-05-06 @ 1:25 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04019600
Status:
SUSPENDED
Last Update Posted:
2021-08-10
First Post:
2019-07-11
Brief Title:
Screening of Pulmonary Hypertension in Methamphetamine Abusers
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Screening of Pulmonary Hypertension in Methamphetamine Abusers SOPHMA Rationale and Design of a Multicenter Cross-sectional Study
Status:
SUSPENDED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment in out-patient clinic has been suspended due to COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOPHMA
Brief Summary:
Methamphetamine is misuse if classified as a likely risk factor for pulmonary arterial hypertension PAH Nevertheless the actual prevalence of and a screening strategy for PAH in methamphetamine users have not been established In this study the prevalence of PAH will be investigated and its independent risk factors among methamphetamine users will be identified
Detailed Description:
Methamphetamine is a potent central nervous system stimulant originally prescribed for individuals with neuropsychiatric diseases Owing to its highly addictive nature illicit use has emerged as a major public health problem worldwide It causes methamphetamine use disorders and also affects cardiovascular CV system
PAH is one of those CV complications and is devastating and often life-threatening In a subsequent retrospective cohort patients with idiopathic PAH were found to have a much higher prevalence of prior use of methamphetamine andor its related compounds compared with patients with chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to a known associated condition Although current international guidelines recognize methamphetamines as a likely cause of drug-induced PAH almost nothing is known about its prevalence and incidence amongst methamphetamine users
Besides since patients with PAH often remain asymptomatic in the early phase the diagnosis is often made late in the course of the disease when most small pulmonary arteries have been obliterated rendering therapy ineffective Although the prognosis of patients with methamphetamine-associated PAH appears to be much worse than for those with idiopathic PAH international guidelines and expert consensus have not considered screening for PAH in asymptomatic methamphetamine users
This study will apply a current guideline-recommended PAH screening algorithm for systemic sclerosis to a large cohort of unselected methamphetamine users in Hong Kong The study objectives include 1 to describe the prevalence of PAH among methamphetamine users using a current guidelines-recommended screening algorithm for PAH in systemic sclerosis 2 to identify independent risk factors for PAH in methamphetamine users and 3 to develop a prediction model for PAH in methamphetamine users
PAH is one of those CV complications and is devastating and often life-threatening In a subsequent retrospective cohort patients with idiopathic PAH were found to have a much higher prevalence of prior use of methamphetamine andor its related compounds compared with patients with chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to a known associated condition Although current international guidelines recognize methamphetamines as a likely cause of drug-induced PAH almost nothing is known about its prevalence and incidence amongst methamphetamine users
Besides since patients with PAH often remain asymptomatic in the early phase the diagnosis is often made late in the course of the disease when most small pulmonary arteries have been obliterated rendering therapy ineffective Although the prognosis of patients with methamphetamine-associated PAH appears to be much worse than for those with idiopathic PAH international guidelines and expert consensus have not considered screening for PAH in asymptomatic methamphetamine users
This study will apply a current guideline-recommended PAH screening algorithm for systemic sclerosis to a large cohort of unselected methamphetamine users in Hong Kong The study objectives include 1 to describe the prevalence of PAH among methamphetamine users using a current guidelines-recommended screening algorithm for PAH in systemic sclerosis 2 to identify independent risk factors for PAH in methamphetamine users and 3 to develop a prediction model for PAH in methamphetamine users
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None