ST Elevated Myocardial InfarctionPROPHET-ACSNCT04002739
PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome
A study testing Polygraphy in people with ST Elevated Myocardial Infarction and Sleep-Disordered Breathing, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ST Elevated Myocardial Infarction, Sleep-Disordered Breathing, Sleep
- What is being tested?
- Polygraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2019to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of ACS (STEMI or NSTEMI) admitted to CCU of our institution within 72 hours from Myocardial Infarct (MI)
- Age between 18 and 85 years old
Who cannot join
- Previous diagnosis of OSA or ongoing CPAP treatment
- Chronic/Home Oxygen therapy
- Cardiogenic shock
- Heart failure exacerbation
- use of mechanical ventilation
- Active use of benzodiazepines
- Pregnancy or breastfeeding
- Unable to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Pier-Valerio Mari, MD, (+39) 3313881904, piervalerio.mari@gmail.com
Pier-Valerio Mari, MD
About this study
Official title: PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome (PROPHET-ACS)
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.
Read the 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 36.9%-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.
- Conditions
- ST Elevated Myocardial Infarction, Sleep-Disordered Breathing, Sleep, NSTEMI - Non-ST Segment Elevation MI
- Being tested
- Polygraphy
- Keywords
- STEMI, NSTEMI, Sleep Apnea, OSA
- Medical subject headings
- ST Elevation Myocardial Infarction, Sleep Apnea Syndromes, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolygraphyDiagnostic test
Also called VitalNight Plus
Patients will perform polygraphy during the CCU stay (baseline) and, if found to have a diagnosis of Obstructive Sleep Apnea (OSA) syndrome, will complete the study with a follow-up visit at 90-day (follow-up). Diagnosis of OSA syndrome will require an Apnea / Hypopnea Index (AHI) more than 5 events per hour.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Acute Coronary Syndrome (ACS) | Experimental | Patients admitted to a Coronary Care Unit (CCU) with a new diagnosis of ST Elevation Myocardial Infarction (STEMI) or Non ST Elevation Myocardial Infarction (NSTEMI). Patients are eligible within 72 hours from the admission in CCU. All patients admitted to CCU are going to perform the following procedures/exams as standard clinical practice: coronary angiogram, blood samples, echocardiogram, 24-hour Holter EKG Monitoring. The experimental arm will also perform a polygraphy during CCU stay, a bioelectrical impedance and will complete baseline questionnaires assessing daytime sleepiness such as Epworth Sleepiness Scale (ESS), STOP-BANG and Mallampati score. After the discharge from CCU, patients that had a diagnosis of Obstructive Sleep Apnea Syndrome are going to complete a follow up visit in 90 days undergoing a new polygraphy, bioelectrical impedance, questionnaires (ESS, STOP-BANG and Mallampati Score), echocardiogram. Receives: Diagnostic Test: Polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Obstructive Sleep Apnea severity in Acute Coronary Syndrome
Change of Obstructive Sleep Apnea (OSA) severity from baseline to 90 days in patients affected by an Acute Coronary Syndrome (ACS). Within 72 hours from admission, patients will perform a polygraphy and the Apnea / Hypopnea Index (AHI) will be determined. OSA syndrome is defined by AHI more than 5.0 per hour and can be mild (AHI between 5.0 and 15), moderate (AHI between 15.0 and 30.0) or severe (AHI more than 30.0).
When a diagnosis of OSA is confirmed, the patient will have a follow up visit with a new polygraphy and AHI will be defined again. Patients are not going to receive any treatment for the sleep-disorder breathing between baseline and 90-day. The difference between AHI baseline and AHI of the follow-up will define the evolution of OSA severity and will show an improved, stable or worsened sleep-disorder.
Measured: Baseline, 90 days
Secondary outcomes (25)
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Coronary
Culprit vessel as a 90-day predictor of spontaneous reduction of at least 15.0 events per hour of Apnea / Hypopnea Index (AHI) from baseline evaluation with polysomnography. The primary statistic of interest will be the effect size.
Measured: Baseline
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Echocardiography
Ejection fraction (EF) and Systolic Pulmonary Artery Pressure (SPAP) as a 90-day predictors of spontaneous reduction of at least 15.0 events per hour of Apnea / Hypopnea Index (AHI) from baseline evaluation with polysomnography. The primary statistic of interest will be the effect size.
Measured: Baseline, 90 days
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - EKG Holter
Arrhythmias, mean heart rate, SDNN, r-MSSD, pNN50%, Mean Log LF/HF as a 90-day predictors of spontaneous reduction of at least 15.0 events per hour of Apnea / Hypopnea Index (AHI) from baseline evaluation with polysomnography. The primary statistic of interest will be the effect size.
Measured: Baseline
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Bioelectrical impedance
Resistance and reactance as a 90-day predictors of spontaneous reduction of at least 15.0 events per hour of Apnea / Hypopnea Index (AHI) from baseline evaluation with polysomnography. The primary statistic of interest will be the effect size.
Measured: Baseline, 90 days
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - ESS
Epworth Sleepiness Scale (ESS) as a 90-day predictor of spontaneous reduction of at least 15.0 events per hour of Apnea / Hypopnea Index (AHI) from baseline evaluation with polysomnography. The total score ranges from 0 to 24. Respondents are asked to rate, on a 4-point scale (0-1-2-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The primary statistic of interest will be the effect size.
Measured: Baseline, 90 days
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - STOP-BANG
STOP-BANG as a 90-day predictor of spontaneous reduction of at least 15.0 events per hour of Apnea / Hypopnea Index (AHI) from baseline evaluation with polysomnography. The test is a baseline screening evaluation of Obstructive Sleep Apnea (OSA) diagnosis. A score <3 is not predictive of OSA while a final result ≥3 is suggestive of OSA. The primary statistic of interest will be the effect size.
Measured: Baseline, 90 days
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Mallampati Score
Mallampati Score as a 90-day predictor of spontaneous reduction of at least 15.0 events per hour of Apnea / Hypopnea Index (AHI) from baseline evaluation with polysomnography.
It is a baseline evaluation of the back of a patient's throat by asking the patient to open the mouth and extend the tongue. The anatomy of the oral cavity is visualized; specifically, the assessor notes whether the base of the uvula, faucial pillars and soft palate are visible.
A Mallampati Score ≤2 is not predictive of OSA while a final result <3 is suggestive of OSA.
The primary statistic of interest will be the effect size.
Measured: Baseline
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Serological domain
Blood samples result such as CK, Creatin kinase, Glucose, Cholesterol, nt-proBNP, CRP, Creatinin as a 90-day predictor of spontaneous reduction of at least 15.0 events per hour of Apnea / Hypopnea Index (AHI) from baseline evaluation with polysomnography.
Measured: Baseline
Prevalence of Obstructive Sleep Apnea (OSA)
Prevalence expressed as the number of events per hour of the sleep apneas due to obstructive cause in patients with a diagnosis of Obstructive Sleep Apnea (OSA) Syndrome assessed with polysomnography. Obstructive Sleep Apnea will be defined as an Obstructive Apnea Index per hour more than 5.0/h in polysomnography.
Measured: Baseline, 90 days
Evolution of Obstructive Sleep Apnea Syndrome
The change of the Obstructive Apnea Index (expressed as the number of events per hour) from the baseline to the 90-day evaluation.
Measured: Baseline, 90 days
Prevalence of Central Sleep Apnea (CSA)
Prevalence expressed as the number of events per hour of the sleep apneas due to central cause in patients with a diagnosis of Obstructive Sleep Apnea (OSA) Syndrome assessed with polysomnography. Central Sleep Apnea will be defined as a Central Apnea Index per hour more than 5.0/h in polysomnography.
Measured: Baseline, 90 days
Evolution of Central Sleep Apnea (CSA)
The change of the Central Apnea Index (expressed as the number of events per hour) from the baseline to the 90-day evaluation.
Measured: Baseline, 90 days
Culprit vessel
Evaluate the baseline prevalence of the culprit vessel responsible for Acute Coronary Syndrome (ACS). Culprit's vessels are one or more of the following:
- Left Anterior Descending Artery
- Circumflex artery
- Right Coronary Artery
Measured: Baseline
Blood samples characteristics
Evaluate the baseline prevalence and the potential correlation in acute coronary syndrome (ACS) with obstructive sleep apnea (OSA) of serological biomarkers such as: Troponins, creatinkinase, Creatinin, nt-proBNP, C reactive protein, Glucose, Cholesterol.
Measured: Baseline
Bioelectrical impedance characteristics
Evaluate the baseline prevalence and the changing after 90 days in acute coronary syndrome (ACS) with obstructive sleep apnea (OSA) of bioelectrical impedance, in particular, reactance and impedance.
Measured: Baseline, 90 days
Evaluation of Ejection Fraction
Ejection fraction (EF) is a measurement made by echocardiography and expressed as a percentage that describes how much blood the left ventricle pumps out with each contraction. Evaluation of EF will be performed in baseline and after 90 days with echocardiography.
The EF is classified as:
EF≥55%: Normal EF 40%<EF<55%: Heart failure with preserved ejection fraction (HFpEF) EF≤40%: Heart failure
Measured: Baseline, 90 days
Evaluation of Systolic Pulmonary Artery Pressure (SPAP)
The Systolic Pulmonary Artery Pressure (SPAP) is an echocardiographic value expressed as mercury millimetres (mmHg) that describes the likelihood of the presence of Pulmonary Hypertension (PH). Evaluation of Systolic Pulmonary Artery Pressure (SPAP) will be performed in baseline and after 90 days with echocardiography.
The SPAP is classified as:
SPAP≤35 mmHg: Normal 35mmHg<SPAP≤50mmHg: Possible PH SPAP>50mmHg: Likely PH
Measured: Baseline, 90 days
Evolution of Ejection Fraction
Ejection fraction (EF) is a measurement made by echocardiography and expressed as a percentage that describes how much blood the left ventricle pumps out with each contraction. The difference from baseline to 90 days will be calculated. The minimal important difference is defined as a change of at least 8% of the EF baseline value.
Measured: Baseline, 90 days
Evolution of Systolic Pulmonary Artery Pressure (SPAP)
The Systolic Pulmonary Artery Pressure (SPAP) is an echocardiographic value expressed as mercury millimetres (mmHg) that describes the likelihood of the presence of Pulmonary Hypertension (PH). The difference from baseline to 90 days will be calculated. The minimal important difference is defined as a change of at least 5mmHg from the SPAP baseline value.
Measured: Baseline, 90 days
Polysomnographic characteristics
Within 72 hours from admission in Coronary Care Unit (CCU), patients will perform a polygraphy and the Apnea / Hypopnea Index (AHI) will be determined. OSA syndrome is defined by AHI more than 5.0 per hour and can be mild (AHI between 5.0 and 15), moderate (AHI between 15.0 and 30.0) or severe (AHI more than 30.0). When a diagnosis of OSA is confirmed, the patient will have a follow up visit with a new polygraphy and AHI will be defined again.
Measured: Baseline, 90 days
Evaluation of daytime sleepiness
Assessment of sleepiness status using the questionnaire "Epworth Sleepiness Score" (ESS). The total score ranges from 0 to 24. Respondents are asked to rate, on a 4-point scale (0-1-2-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. A result in ESS score more than 10 is suggestive for daytime sleepiness.
Measured: Baseline, 90 days
Evolution of daytime sleepiness
Change from baseline to 90 days of the questionnaire "Epworth Sleepiness Score" (ESS). The total score ranges from 0 to 24. Respondents are asked to rate, on a 4-point scale (0-1-2-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The difference from baseline to 90 days will be calculated. The minimal important difference is defined as a reduction of at least 2 points of the baseline value.
Measured: Baseline, 90 days
Baseline screening of Obstructive Sleep Apnea
Baseline screening evaluation of Obstructive Sleep Apnea (OSA) diagnosis using the validated questionnaire "STOP-BANG". A score <3 is not predictive of OSA while a final result ≥3 is suggestive of OSA.
Measured: Baseline, 90 days
Baseline prediction of Obstructive Sleep Apnea
Baseline evaluation of the back of a patient's throat by asking the patient to open the mouth and extend the tongue. The anatomy of the oral cavity is visualized; specifically, the assessor notes whether the base of the uvula, faucial pillars and soft palate are visible. Four classes can be distinguished:
Class I: Soft palate, uvula, fauces, pillars visible. Class II: Soft palate, major part of uvula, fauces visible. Class III: Soft palate, base of uvula visible. Class IV: Only hard palate visible. A Mallampati Score ≤2 is not predictive of OSA while a final result <3 is suggestive of OSA.
Measured: Baseline
24 hours-EKG Holter baseline characteristics
Evaluate the baseline prevalence and the potential correlation in acute coronary syndrome (ACS) with obstructive sleep apnea (OSA) of 24 hours EKG Holter using values such as: arrhythmias, mean heart rate, SDNN, r-MSSD, pNN50%, Mean Log LF/HF.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start15 Jun 2019
- Primary completion15 Sep 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevated Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The target sample size (for primary aim) is 37. Patients to be enrolled: 50 Patients to be screened: 70 This sample size (n=37) has been defined as sufficient to detect a difference of 15.0 in mean AHI Index between baseline and 3-month follow up with a power of 95% and a 5% (two-sided) significance level. The sample size was calculated and based on a previous pilot study from our institution and reported in "More information" section. Notably, attrition has been proposed due to the possible loss of follow up at 90-day: thus, we decided to enroll 13 more patients affected by OSA for a total of 50 patients. Moreover, given a CCU prevalence of OSA in ACS of 73%, a total of 70 patients affected by ACS are expected to be screened in order to collect 50 OSA target sample size population.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Richeldi, PhD, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002739
- Sponsor's protocol ID
- 2589
- Acronym
- PROPHET-ACS
- Status last verified
- Aug 2019
- First submitted
- 24 Jun 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome (PROPHET-ACS)
- ClinicalTrials.gov ID
- NCT04002739
- Acronym / sponsor ID
- PROPHET-ACS / 2589
- Conditions
- ST Elevated Myocardial Infarction, Sleep-Disordered Breathing, Sleep, NSTEMI - Non-ST Segment Elevation MI
- Keywords
- STEMI, NSTEMI, Sleep Apnea, OSA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Sep 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 36.9%-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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The target sample size (for primary aim) is 37. Patients to be enrolled: 50 Patients to be screened: 70 This sample size (n=37) has been defined as sufficient to detect a difference of 15.0 in mean AHI Index between baseline and 3-month follow up with a power of 95% and a 5% (two-sided) significance level. The sample size was calculated and based on a previous pilot study from our institution and reported in "More information" section. Notably, attrition has been proposed due to the possible loss of follow up at 90-day: thus, we decided to enroll 13 more patients affected by OSA for a total of 50 patients. Moreover, given a CCU prevalence of OSA in ACS of 73%, a total of 70 patients affected by ACS are expected to be screened in order to collect 50 OSA target sample size population.
| Arm | Type | Receives |
|---|---|---|
| Patients with Acute Coronary Syndrome (ACS) | Experimental | Diagnostic Test: PolygraphyPatients admitted to a Coronary Care Unit (CCU) with a new diagnosis of ST Elevation Myocardial Infarction (STEMI) or Non ST Elevation Myocardial Infarction (NSTEMI). Patients are eligible within 72 hours from the admission in CCU. All patients admitted to CCU are going to perform the following procedures/exams as standard clinical practice: coronary angiogram, blood samples, echocardiogram, 24-hour Holter EKG Monitoring. The experimental arm will also perform a polygraphy during CCU stay, a bioelectrical impedance and will complete baseline questionnaires assessing daytime sleepiness such as Epworth Sleepiness Scale (ESS), STOP-BANG and Mallampati score. After the discharge from CCU, patients that had a diagnosis of Obstructive Sleep Apnea Syndrome are going to complete a follow up visit in 90 days undergoing a new polygraphy, bioelectrical impedance, questionnaires (ESS, STOP-BANG and Mallampati Score), echocardiogram. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with a diagnosis of ACS (STEMI or NSTEMI) admitted to CCU of our institution within 72 hours from Myocardial Infarct (MI)
- Age between 18 and 85 years old
Key exclusion criteria (8 listed)
- Previous diagnosis of OSA or ongoing CPAP treatment
- Chronic/Home Oxygen therapy
- Cardiogenic shock
- Heart failure exacerbation
- use of mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolygraphyAlso: VitalNight PlusPatients will perform polygraphy during the CCU stay (baseline) and, if found to have a diagnosis of Obstructive Sleep Apnea (OSA) syndrome, will complete the study with a follow-up visit at 90-day (follow-up). Diagnosis of OSA syndrome will require an Apnea / Hypopnea Index (AHI) more than 5 events per hour. | Diagnostic test | Patients with Acute Coronary Syndrome (ACS) |
Primary outcome
Evolution of Obstructive Sleep Apnea severity in Acute Coronary Syndrome
Time frame: Baseline, 90 days
Change of Obstructive Sleep Apnea (OSA) severity from baseline to 90 days in patients affected by an Acute Coronary Syndrome (ACS). Within 72 hours from admission, patients will perform a polygraphy and the Apnea / Hypopnea Index (AHI) will be determined. OSA syndrome is defined by AHI more than 5.0 per hour and can be mild (AHI between 5.0 and 15), moderate (AHI between 15.0 and 30.0) or severe (AHI more than 30.0). When a diagnosis of OSA is confirmed, the patient will have a follow up visit with a new polygraphy and AHI will be defined again. Patients are not going to receive any treatment for the sleep-disorder breathing between baseline and 90-day. The difference between AHI baseline and AHI of the follow-up will define the evolution of OSA severity and will show an improved, stable or worsened sleep-disorder.
25 secondary outcomes
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Coronary
Time frame: Baseline
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Echocardiography
Time frame: Baseline, 90 days
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - EKG Holter
Time frame: Baseline
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Bioelectrical impedance
Time frame: Baseline, 90 days
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - ESS
Time frame: Baseline, 90 days
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - STOP-BANG
Time frame: Baseline, 90 days
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Mallampati Score
Time frame: Baseline
Predictors of spontaneous reduction of Obstructive Sleep Apnea severity - Serological domain
Time frame: Baseline
Prevalence of Obstructive Sleep Apnea (OSA)
Time frame: Baseline, 90 days
Evolution of Obstructive Sleep Apnea Syndrome
Time frame: Baseline, 90 days
Prevalence of Central Sleep Apnea (CSA)
Time frame: Baseline, 90 days
Evolution of Central Sleep Apnea (CSA)
Time frame: Baseline, 90 days
Culprit vessel
Time frame: Baseline
Blood samples characteristics
Time frame: Baseline
Bioelectrical impedance characteristics
Time frame: Baseline, 90 days
Evaluation of Ejection Fraction
Time frame: Baseline, 90 days
Evaluation of Systolic Pulmonary Artery Pressure (SPAP)
Time frame: Baseline, 90 days
Evolution of Ejection Fraction
Time frame: Baseline, 90 days
Evolution of Systolic Pulmonary Artery Pressure (SPAP)
Time frame: Baseline, 90 days
Polysomnographic characteristics
Time frame: Baseline, 90 days
Evaluation of daytime sleepiness
Time frame: Baseline, 90 days
Evolution of daytime sleepiness
Time frame: Baseline, 90 days
Baseline screening of Obstructive Sleep Apnea
Time frame: Baseline, 90 days
Baseline prediction of Obstructive Sleep Apnea
Time frame: Baseline
24 hours-EKG Holter baseline characteristics
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- "Determinants and evolution of obstructive sleep apnea syndrome after myocardial infarction". The sample size of the trial PROPHET-ACS was derived from this pilot study presented as abstract at the European Sleep and Breathing Conference 2019, Marseille.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Richeldi, PhD study director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygraphy in people with ST Elevated Myocardial Infarction and Sleep-Disordered Breathing, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pier-Valerio Mari, MD ((+39) 3313881904, piervalerio.mari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of Obstructive Sleep Apnea severity in Acute Coronary Syndrome (time frame: Baseline, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.