Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04002739
Status:
UNKNOWN
Last Update Posted:
2019-08-13
First Post:
2019-06-24
Brief Title:
PRedictOrs PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
PRedictOrs PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome PROPHET-ACS
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROPHET-ACS
Brief Summary:
Obstructive Sleep Apnea OSA is a well-known disorder of upper airways collapse during sleep time leading to oxygen desaturation and sleep fragmentation Despite being increasingly recognized as cardiovascular risk the effect of OSA on clinical outcomes after Acute Coronary Syndrome ACS is not fully defined Also OSA syndrome is highly prevalent in ACS and may be related to the deterioration of cardiac function resulting in worsening of the severity of sleep apnea or the intermittent hypoxia could be cardio-protective via the ischemic preconditioning event Serial sleep studies have shown the progressive reduction of the Apnea Hypopnea Index AHI from the admission in Coronary Care Unit CCU to 6 weeks 12 weeks and 6-month follow up making necessary to re-assess the severity of OSA after discharge Therefore further research in this field is necessary to screen and predict those ACS patients who may experience a change in their AHI index over time
Detailed Description:
Obstructive Sleep Apnea OSA is a well-known disorder of upper airways collapse during sleep time leading to oxygen desaturation sleep fragmentation tissue suffering and hypercapnia The repeated airways collapse leads to a fall of blood saturation levels during sleep time and it is linked to daytime sleepiness road traffic accidents cognitive deficits depression myocardial infarction pulmonary hypertension and stroke
Despite being increasingly recognized as a major cardiovascular risk the effect of OSA on clinical outcomes after Coronary Artery Disease CAD is not fully defined The presentation of Acute Coronary Syndrome ACS can be unstable angina non-ST Elevation Myocardial Infarction NSTEMI or ST-Elevation Myocardial Infarction STEMI Sleep apnea prevalence in the context of acute coronary syndromes ACS is sizeable varying from 369-82 when polysomnography is executed briefly after admission in Cardiovascular Care Unit CCU The high prevalence of OSA in ACS may be related to the deterioration of cardiac function resulting in worsening of the severity of sleep apnea In converse OSA has also been proposed as a protective factor in CAD The intermittent hypoxia related to OSA could have a cardio-protective role during acute ACS via the phenomenon of ischemic preconditioning showing that in acute MI patients higher AHI was associated with lower peak troponin-T levels in partially and fully adjusted models
Furthermore the improvement of cardiac outcomes at the follow-up post-discharge seems to positively influence the severity of OSA In particular serial sleep studies have interestingly shown a progressive reduction of the AHI at 6 weeks 12 weeks and 6-month follow up making necessary to re-assess the severity of OSA after discharge Therefore further research in this field is necessary to screen and predict those ACS patients with a diagnosis of OSA made at admission in CCU who may experience a change in their AHI index over time in order to identify those with a potential unfavourable prognosis
Despite being increasingly recognized as a major cardiovascular risk the effect of OSA on clinical outcomes after Coronary Artery Disease CAD is not fully defined The presentation of Acute Coronary Syndrome ACS can be unstable angina non-ST Elevation Myocardial Infarction NSTEMI or ST-Elevation Myocardial Infarction STEMI Sleep apnea prevalence in the context of acute coronary syndromes ACS is sizeable varying from 369-82 when polysomnography is executed briefly after admission in Cardiovascular Care Unit CCU The high prevalence of OSA in ACS may be related to the deterioration of cardiac function resulting in worsening of the severity of sleep apnea In converse OSA has also been proposed as a protective factor in CAD The intermittent hypoxia related to OSA could have a cardio-protective role during acute ACS via the phenomenon of ischemic preconditioning showing that in acute MI patients higher AHI was associated with lower peak troponin-T levels in partially and fully adjusted models
Furthermore the improvement of cardiac outcomes at the follow-up post-discharge seems to positively influence the severity of OSA In particular serial sleep studies have interestingly shown a progressive reduction of the AHI at 6 weeks 12 weeks and 6-month follow up making necessary to re-assess the severity of OSA after discharge Therefore further research in this field is necessary to screen and predict those ACS patients with a diagnosis of OSA made at admission in CCU who may experience a change in their AHI index over time in order to identify those with a potential unfavourable prognosis
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