Last reviewed · How we verify
NCT04002739: PROPHET-ACS
PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome
NA trial testing Polygraphy in ST Elevated Myocardial Infarction in 50 participants. Status unknown.
15 September 2019
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 50 |
| Start date | 15 June 2019 |
| Primary completion | 15 September 2019 |
| Estimated completion | 15 December 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Polygraphy
Conditions studied
- ST Elevated Myocardial Infarction — all drugs for ST Elevated Myocardial Infarction →
- Sleep-Disordered Breathing — all drugs for Sleep-Disordered Breathing →
- Sleep — all drugs for Sleep →
- NSTEMI - Non-ST Segment Elevation MI — all drugs for NSTEMI - Non-ST Segment Elevation MI →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
Adults 18 to 85, any sex, with ST Elevated Myocardial Infarction or Sleep-Disordered Breathing. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04002739
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Polygraphy
Trials testing the same drug.
- NCT06810479 — A Study Comparing Two Mandibular Advancement Devices in the Treatment of Sleep Apnea · NA · not yet recruiting
- NCT05204004 — The Sunrise OSA Trial · NA · completed
- NCT04448470 — Daytime Sleepiness in Patients With the Assessment of a Sleep-related Respiratory Disorder · unknown
Other recruiting trials for ST Elevated Myocardial Infarction
Currently open trials in the same condition.
- NCT05491200 — Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients · Phase 4 · recruiting
Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
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- NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
- NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
- NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
- NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04002739 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 13 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04002739.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing