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| Name | Class |
|---|---|
| King Khalid University | OTHER |
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This is a non-CTIMP randomised controlled trial looking at the utilisation of telemedicine devices to provide remote, clinically necessary, diagnostic information, without the need for hospital attendance that patients will take home with them following admission to hospital with a heart attack.
Following hospital admission with a heart attack, telemedicine equipment can provide patients with remote, clinically necessary diagnostic information without the need for hospital attendance, which they can take home when they discharge from the hospital. In this project, patients known to be at high risk of ACS are equipped and empowered to seek urgent medical attention without visiting the hospital, if they experience symptoms, and to determine whether or not to seek emergency treatment, with an immediate remote specialist consultation, as assessed by validated technology.
Those enrolled in the intervention group will be offered telemedicine packages upon discharge from the hospital. Those enrolled in the active arm will have their telemedicine package provided to the trial team when they conduct an ECG and seek medical attention. In contrast, in the control group, routine clinical care will be provided, as well as follow up by phone over 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm | Active Comparator | Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months. |
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| Control Arm | Placebo Comparator | Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Arm | Other | Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hospital Readmission at 6 Months | At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups. | 6 months |
| Emergency Department Visits at 6 Months | Any emergency department visits not requiring admission or further intervention will be compared in both study groups at 6 months of follow up. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Length of stay at 3, 6, and 9 months will be compared in both study groups. | From discharge to 9 months follow-up |
| All-cause Mortality | At 6 months of follow up, compare all-cause mortality, morbidity |
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Inclusion Criteria:
1 ACS Patients diagnosed with elevated hs-cTnI I who have undergone coronary intervention for NSTEMI or STEMI or unstable angina.
2 In addition, the participant should have at least one additional cardiovascular risk factor:
3 Access to a smartphone or smart device.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramzi Y Khamis, MB ChB PhD FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28728745 | Background | Kwok CS, Wong CW, Shufflebotham H, Brindley L, Fatima T, Shufflebotham A, Barker D, Pawala A, Heatlie G, Mamas MA. Early Readmissions After Acute Myocardial Infarction. Am J Cardiol. 2017 Sep 1;120(5):723-728. doi: 10.1016/j.amjcard.2017.05.049. Epub 2017 Jun 15. | |
| 31407368 | Background | Wang H, Zhao T, Wei X, Lu H, Lin X. The prevalence of 30-day readmission after acute myocardial infarction: A systematic review and meta-analysis. Clin Cardiol. 2019 Oct;42(10):889-898. doi: 10.1002/clc.23238. Epub 2019 Aug 12. |
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Once the study is complete and analysed, whilst individual patient results will not be disclosed, the overall research findings may be submitted for publication in a scientific journal and presented at scientific conferences following the completion of the study. A summary of the research findings will be uploaded onto the Imperial College London website. All data will be anonymised and kept confidential.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Arm | Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months. Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months. |
| FG001 | Control Arm | Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Arm | Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months. Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age was recorded in completed years at the time of randomization and summarized as mean and standard deviation for each study arm. This measure reflects the chronological age of all randomized participants included in the baseline analysis set. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Hospital Readmission at 6 Months | At 6 months of follow up, compare formal admissions and not emergency room visits in intervention to control groups. | Time to readmission | Posted | Count of Participants | Participants | No | 6 months |
|
Time to event 9-month follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Arm | Patients will be discharged from the hospital with the telemedicine package. If the patient develops possible cardiac symptoms and seeks medical attention, the data provided by the telemedicine package will be acted upon, as appropriate, by the trial cardiology team. With remote follow up over the phone at 3, 6 and 9 months. Active Arm: Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Ramzi Khamis | Imperial College London | 0207 594 6842 | r.khamis@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2021 | Sep 24, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2022 | Sep 24, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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A total of 338 patients will be randomised 1:1 to the 2 trial arms over 9 months.
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|
| Control Arm | Other | Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. |
|
| 6 months |
| Number of Participants With Major Adverse Cardiac Events (MACE) at 9 Months | Number of participants with major adverse cardiac events (MACE) at 9 months follow-up. | 9 months |
| Medical Intervention | Compare Medical intervention for for acute coronary syndromes or heart failure, including coronary angiography/ angioplasty, injectable therapy or oxygen therapy for both study groups when readmission to hospital. | 6 months |
| 9 Months Readmission Rates | The readmission rates for 9 months will be compared in both study groups. | 9 months |
| Patient-Reported Quality of Life - 3 Months | Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 3 months post-discharge, and follow-up scores were compared with baseline values. | 3 months |
| Patient-Reported Quality of Life - 6 Months | Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 6 months post-discharge, and follow-up scores were compared with baseline values. | 6 months |
| Patient-Reported Quality of Life - 9 Months | Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 9 months post-discharge, and follow-up scores were compared with baseline values. | 9 months |
| 25237046 | Background | Southern DA, Ngo J, Martin BJ, Galbraith PD, Knudtson ML, Ghali WA, James MT, Wilton SB. Characterizing types of readmission after acute coronary syndrome hospitalization: implications for quality reporting. J Am Heart Assoc. 2014 Sep 18;3(5):e001046. doi: 10.1161/JAHA.114.001046. |
| 28153989 | Background | Dreyer RP, Dharmarajan K, Kennedy KF, Jones PG, Vaccarino V, Murugiah K, Nuti SV, Smolderen KG, Buchanan DM, Spertus JA, Krumholz HM. Sex Differences in 1-Year All-Cause Rehospitalization in Patients After Acute Myocardial Infarction: A Prospective Observational Study. Circulation. 2017 Feb 7;135(6):521-531. doi: 10.1161/CIRCULATIONAHA.116.024993. |
| 31941686 | Background | Khera R, Wang Y, Bernheim SM, Lin Z, Krumholz HM. Post-discharge acute care and outcomes following readmission reduction initiatives: national retrospective cohort study of Medicare beneficiaries in the United States. BMJ. 2020 Jan 15;368:l6831. doi: 10.1136/bmj.l6831. |
| 25046174 | Background | Ben-Assa E, Shacham Y, Golovner M, Malov N, Leshem-Rubinow E, Zatelman A, Oren Shamir A, Rogowski O, Roth A. Is telemedicine an answer to reducing 30-day readmission rates post-acute myocardial infarction? Telemed J E Health. 2014 Sep;20(9):816-21. doi: 10.1089/tmj.2013.0346. Epub 2014 Jul 21. |
| 32283124 | Background | Garcia S, Albaghdadi MS, Meraj PM, Schmidt C, Garberich R, Jaffer FA, Dixon S, Rade JJ, Tannenbaum M, Chambers J, Huang PP, Henry TD. Reduction in ST-Segment Elevation Cardiac Catheterization Laboratory Activations in the United States During COVID-19 Pandemic. J Am Coll Cardiol. 2020 Jun 9;75(22):2871-2872. doi: 10.1016/j.jacc.2020.04.011. Epub 2020 Apr 10. No abstract available. |
| 32473113 | Background | Marijon E, Karam N, Jost D, Perrot D, Frattini B, Derkenne C, Sharifzadehgan A, Waldmann V, Beganton F, Narayanan K, Lafont A, Bougouin W, Jouven X. Out-of-hospital cardiac arrest during the COVID-19 pandemic in Paris, France: a population-based, observational study. Lancet Public Health. 2020 Aug;5(8):e437-e443. doi: 10.1016/S2468-2667(20)30117-1. Epub 2020 May 27. |
| 38588928 | Derived | Alshahrani NS, Hartley A, Howard J, Hajhosseiny R, Khawaja S, Seligman H, Akbari T, Alharbi BA, Bassett P, Al-Lamee R, Francis D, Kaura A, Kelshiker MA, Peters NS, Khamis R. Randomized Trial of Remote Assessment of Patients After an Acute Coronary Syndrome. J Am Coll Cardiol. 2024 Jun 11;83(23):2250-2259. doi: 10.1016/j.jacc.2024.03.398. Epub 2024 Apr 6. |
| BG001 | Control Arm | Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. |
| BG002 | Total | Total of all reporting groups |
All randomized participants with available age data were included in this analysis. This measure reflects the age of participants included in the baseline analysis population. |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Current or ex-smoker | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| OG001 | Control Arm | Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. |
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| Primary | Emergency Department Visits at 6 Months | Any emergency department visits not requiring admission or further intervention will be compared in both study groups at 6 months of follow up. | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | Length of Stay | Length of stay at 3, 6, and 9 months will be compared in both study groups. | Total length of stay 0-9 months | Posted | Mean | Standard Deviation | Days | From discharge to 9 months follow-up |
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| Secondary | All-cause Mortality | At 6 months of follow up, compare all-cause mortality, morbidity | All-cause Mortality at 6-month follow-up | Posted | Number | 95% Confidence Interval | percentage of Events (95% CI) | 6 months |
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| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE) at 9 Months | Number of participants with major adverse cardiac events (MACE) at 9 months follow-up. | Number of participants with major adverse cardiac events (MACE) at 9 months follow-up. | Posted | Count of Participants | Participants | 9 months |
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| Secondary | Medical Intervention | Compare Medical intervention for for acute coronary syndromes or heart failure, including coronary angiography/ angioplasty, injectable therapy or oxygen therapy for both study groups when readmission to hospital. | Coronary angiography /angioplasty at 6 months | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 9 Months Readmission Rates | The readmission rates for 9 months will be compared in both study groups. | 3-month readmission data was not a pre-specified secondary outcome in the protocol; therefore, these data are not summarized in an outcome measure table. | Posted | Count of Participants | Participants | 9 months |
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| Secondary | Patient-Reported Quality of Life - 3 Months | Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 3 months post-discharge, and follow-up scores were compared with baseline values. | Analysis includes only participants who completed the SF-36 and SAQ-7 questionnaires at 3-month follow-up time and had corresponding baseline data. The number of participants analyzed is therefore smaller than the number originally assigned to each arm in the Participant Flow, due to non-return of mailed questionnaires and missed follow-up assessments. | Posted | Mean | Standard Deviation | Units on a Scale | 3 months |
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| Secondary | Patient-Reported Quality of Life - 6 Months | Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 6 months post-discharge, and follow-up scores were compared with baseline values. | Analysis includes only participants who completed the SF-36 and SAQ-7 questionnaires at the 6-month follow-up and had corresponding baseline data. The number of participants analyzed is therefore smaller than the number originally assigned to each arm in the Participant Flow, due to non-return of mailed questionnaires and missed follow-up assessments. | Posted | Mean | Standard Deviation | Units on a Scale | 6 months |
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| Secondary | Patient-Reported Quality of Life - 9 Months | Quality of life was assessed using the SF-36 and Seattle Angina Questionnaire-7 (SAQ-7). Both instruments generate domain scores from 0-100, with higher scores indicating better health status or angina-related quality of life. Questionnaires were completed at baseline (pre-discharge) and 9 months post-discharge, and follow-up scores were compared with baseline values. | Analysis includes only participants who completed the SF-36 and SAQ-7 questionnaires at the 9-month follow-up and had corresponding baseline data. The number of participants analyzed is therefore smaller than the number originally assigned to each arm in the Participant Flow, due to non-return of mailed questionnaires and missed follow-up assessments. | Posted | Mean | Standard Deviation | Units on a Scale | 9 months |
|
|
|
| 2 |
| 163 |
| 11 |
| 163 |
| 0 |
| 163 |
| EG001 | Control Arm | Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. Control Arm: Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months. | 2 | 167 | 37 | 167 | 0 | 167 |
| Myocardial infarction | Vascular disorders | Systematic Assessment |
|
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| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| SF-36 role physical |
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| SF-36 role emotional |
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| SF-36 energy / vitality |
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| SF-36 mental health |
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| SF-36 social functioning |
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| SF-36 pain |
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| SF-36 general health |
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| SAQ-7 |
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| SF-36 role emotional |
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| SF-36 energy / vitality |
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| SF-36 mental health |
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| SF-36 social functioning |
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| SF-36 pain |
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| SF-36 general health |
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| SAQ-7 |
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| SF-36 role emotional |
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| SF-36 energy / vitality |
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| SF-36 mental health |
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| SF-36 social functioning |
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| SF-36 pain |
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| SF-36 general health |
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| SAQ-7 |
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