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Screening of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA)
| Condition or disease | Intervention/treatment |
|---|---|
| Methamphetamine Abuse Pulmonary Hypertension | Other: Echocardiography |
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 and/or 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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | Screening of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA): Rationale and Design of a Multicenter, Cross-sectional Study |
| Actual Study Start Date : | December 23, 2019 |
| Estimated Primary Completion Date : | December 22, 2022 |
| Estimated Study Completion Date : | December 22, 2022 |
- Diagnosis of PAH in methamphetamine users [ Time Frame: 3 years ]Diagnosis and subtypes, as well as prevalence of PAH in methamphetamine users
- Risk factors of PAH in methamphetamine users [ Time Frame: 3 years ]Risk factors and a prediction model for PAH in methamphetamine users
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 11, 2019 | ||||||||
| First Posted Date | July 15, 2019 | ||||||||
| Last Update Posted Date | March 10, 2020 | ||||||||
| Actual Study Start Date | December 23, 2019 | ||||||||
| Estimated Primary Completion Date | December 22, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Diagnosis of PAH in methamphetamine users [ Time Frame: 3 years ] Diagnosis and subtypes, as well as prevalence of PAH in methamphetamine users
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
Risk factors of PAH in methamphetamine users [ Time Frame: 3 years ] Risk factors and a prediction model for PAH in methamphetamine users
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Screening of Pulmonary Hypertension in Methamphetamine Abusers | ||||||||
| Official Title | Screening of Pulmonary Hypertension in Methamphetamine Abusers (SOPHMA): Rationale and Design of a Multicenter, Cross-sectional Study | ||||||||
| 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 and/or 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. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | 1 Year | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Participants with a history of methamphetamine use followed-up in the participating substance abuse clinic will be identified via the computerized database of the clinical management system. | ||||||||
| Condition |
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| Intervention | Other: Echocardiography
Demographic data and health risk factors will be collected on day of screening, together with the above tests. Right heart catheterization will be separately arranged in patients with a high echocardiographic probability of PAH. For those with a low-intermediate echocardiographic probability, screening will be repeated within 1 year to ensure true negativity of the original scan.
Other Names:
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 22, 2022 | ||||||||
| Estimated Primary Completion Date | December 22, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
Reference: 13. Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas 2013;25(2):191-2. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Hong Kong | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04019600 | ||||||||
| Other Study ID Numbers | SOPHMA study protocol_v.1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Dr. David Siu, The University of Hong Kong | ||||||||
| Study Sponsor | The University of Hong Kong | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | The University of Hong Kong | ||||||||
| Verification Date | March 2020 | ||||||||
