## Protocol Section
### Identification Module
**NCT ID:** NCT06438315

**Acronym:** SSCORE

**Brief Title:** SuperSaturated Oxygen Comprehensive Observational Registry

**Official Title:** SuperSaturated Oxygen Comprehensive Observational Registry

#### Organization Study ID Info
**ID:** EDC-5731
#### Organization
**Class:** INDUSTRY
**Full Name:** TherOx
### Status Module
#### Completion Date
**Date:** 2029-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** TherOx

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall HF burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.

### Conditions Module

**Conditions:**

- STEMI - ST Elevation Myocardial Infarction

- AMI

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** Treated with SSO2

**Intervention Names:**

- Other: No intervention

**Label:** SSO2

#### Arm Group 2

**Description:** Not treated with SSO2

**Intervention Names:**

- Other: No intervention

**Label:** Control

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control

- SSO2

**Description:** No intervention

**Name:** No intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Rate of composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF

**Measure:** CV death or Heart Failure burden at 1 year

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** Days to the composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF

**Measure:** Time to CV death or HF burden

**Time Frame:** 2 years

**Description:** Rate of all cause mortality

**Measure:** Rate of all cause mortality

**Time Frame:** 2 years

**Description:** Rate of All-cause Hospitalization

**Measure:** Rate of All-cause Hospitalization

**Time Frame:** 2 years

**Description:** Rate of cardiovascular death

**Measure:** Rate of cardiovascular death

**Time Frame:** 2 years

**Description:** Rate of Hospitalization for Heart Failure

**Measure:** Rate of Hospitalization for Heart Failure

**Time Frame:** 2 years

**Description:** composite of rates of CV death, reinfarction, or HF hospitalization

**Measure:** Major Adverse Cardiovascular Events (MACE)

**Time Frame:** 2 years

**Description:** Rate of Reinfarction

**Measure:** Rate of Reinfarction

**Time Frame:** 2 years

**Description:** patient reported outcome, 0 to1, where 0 is death and 1 is perfect health

**Measure:** Change in EQ5D-3L Score

**Time Frame:** 2 years

**Description:** heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best

**Measure:** Change in KCCQ-23 Score

**Time Frame:** 2 years

**Description:** Rate of change of LVEF from baseline to time point

**Measure:** Change in LVEF%

**Time Frame:** 2 years

**Description:** Rate of change of NHYA classification from baseline to time point

**Measure:** Change in NYHA classification scale, I-IV

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Men or women aged 18 years or older
* Presentation with AMI and successful revascularization of the infarct-related artery with PCI
* The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB)

Exclusion Criteria:

* Life expectancy of less than 2 years
* No access to medical records from either the index hospitalization or subsequent outpatient visits
* Currently participating in an investigational drug or device trial

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The study will aim to prospectively enroll 500 subjects not treated with SSO2 Therapy (Prospective Control Cohort), 500 subjects who received SSO2 Therapy in accordance with the product label (SSO2 Treated On-Label) and any subjects that receive SSO2 at an institution that meet criteria IE criteria.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jgardner@zoll.com

**Name:** Jennifer Gardner

**Phone:** 949-300-2811

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Henry Ford Hospital

**Name:** William W O'Neill, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15.

**PMID:** 20031745

**Citation:** David SW, Khan ZA, Patel NC, Metzger DC, Wood FO, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2019 Apr 1;93(5):882-890. doi: 10.1002/ccd.27905. Epub 2018 Sep 28.

**PMID:** 30265429

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009336

- Term: Necrosis

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12155

- Name: Myocardial Infarction

- Relevance: HIGH

- As Found: Myocardial Infarction

- ID: M1072

- Name: ST Elevation Myocardial Infarction

- Relevance: HIGH

- As Found: ST Elevation Myocardial Infarction

- ID: M10282

- Name: Infarction

- Relevance: HIGH

- As Found: Infarction

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009203

- Term: Myocardial Infarction

- ID: D000072657

- Term: ST Elevation Myocardial Infarction

- ID: D000007238

- Term: Infarction

### Misc Info Module

- Version Holder: 2024-05-31
