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The purpose of this study is to assess whether the Index of Microcirculatory Resistance (IMR) can be considered a prognostic predictor for the occurrence of events at one year of follow up after primary Percutaneous Coronary Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) patients.
Any correlation between IMR and the short and medium term outcomes, defined as cardiovascular death, re-Myocardial Infarct (MI), re-hospitalization for Heart Failure (HF), resuscitation or Implantable Cardioverter Defibrillator (ICD) appropriate shock, will be assessed in the study.
Prospective, multicentre study designed to evaluate IMR ability to predict events occurrence, defined as Cardiovascular death, re-MI, re-hospitalization for HF, resuscitation or ICD appropriate shock, during a 1 year follow-up period.
All participants will have the culprit lesion treated following clinical practice and guidelines; Fractional Flow Reserve (FFR) and IMR will be measured after the primary PCI procedure to evaluate treatment success and myocardial viability. Non-culprit lesions will be functionally evaluated through FFR index and will be treated if FFR will show functional stenosis. FFR and IMR will be measured to evaluate treatment success and myocardial viability. Patients will be followed-up at 1m, 6m and 1y periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMR evaluation | Other | Assessment of IMR index in coronaries through PressureWire Certus guidewire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PressureWire Certus guidewire | Device | Assessment of IMR index in coronaries through PressureWire Certus guidewire |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock. | Composite of: cardiovascular death*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shocK, at 1 year. * = timing of mortality evaluation: once culprit lesion has been evaluated through IMR Composite endpoint was evaluated as time to first event, whichever individual component occurred first. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| New Congestive Heart Failure (CHF) During Index Hospitalization | Count of participants with a new CHF during index hospitalization. Hospital stay expected average = 5-10 days | At the end of hospital stay |
| Left Ventricular (LV) Remodeling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Fineschi, MD | Policlinico Le Scotte, Siena | Study Chair |
| Marco Valgimigli, MD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Giovanni Paolo II | Sciacca | Agrigento | 92019 | Italy | ||
| Ospedale Generale Regionale "F. Miulli" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36531736 | Derived | Fineschi M, Verna E, Barioli A, Mezzapelle G, Bartolini D, Turiano G, Guiducci V, Manari A, Lucarelli K, Uguccioni L, Repetto A, Tarantini G. One-year results from the Assessing MICRO-vascular resistances via IMR to predict outcome in ST-elevation myocardial infarction patients with multivessel disease undergoing primary PCI (AMICRO) trial. Front Cardiovasc Med. 2022 Dec 2;9:1051174. doi: 10.3389/fcvm.2022.1051174. eCollection 2022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | STEMI Patient | STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2014 |
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Left Ventricular (LV) remodeling at 1 year; improvement of Ejection Fraction %(EF) assessed by TTE.
A TTE evaluation has been done both at discharge and at 1-year fup.
| 1 year |
| Left Ventricular (LV) Remodeling | Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Systole Volume (LVESV) and Left Ventricular End Diastole Volume (LVEDV) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. | 1 year |
| Left Ventricular (LV) Remodeling | Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Diastole Diameter (LVEDD) and Left Ventricular End Systole Diameter (LVESD) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. | 1 year |
| Left Ventricular (LV) Remodeling | Left Ventricular (LV) remodeling at 1 year; improvement of 16 segments Wall Motion Score Index (WMSI) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. 16WMSI = 1 is considered normokinetic; 16WMSI = 1,5 is considered mild hypokinesia; 16WMSI = 2 is considered hypokinesia; 16WMSI = 2,5 is considered severe hypokinesia; 16WMSI = 3 is considered akinetic. Scale range: from 1 to 3 | 1 year |
| Left Ventricular (LV) Remodeling - Mitral Insufficiency | Left Ventricular (LV) remodeling at 1 year; improvement of mitral insufficiency (MI) values assessed by TTE. A TTE evalutation has been done both at discharge and at 1-year fup. Each row reports the number of participants that have that specific grade of mitral insufficiency. Grade = 0 indicates no MI; grade = 1 indicates mild MI; grade = 2 indicates moderate MI; grade = 3 indicates severe MI | 1 year |
| Need for New Revascularization | Incidence of new revascularizations at 1 year | 1 year |
| Stent Thrombosis | Incidence of stent thrombosis at 1 year | 1 year |
| Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | Evaluation of a better cut-off of IMR index based on primary endpoints events. Table below reports the values of ROC curve. | 1 year |
| Evaluation of Possible Events Predictors | Results of logistic regression model; differences were considered statistically significant when p<0,05. | 1 year |
| Acquaviva delle Fonti |
| BA |
| 70021 |
| Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | FI | 50134 | Italy |
| Azienda Ospedaliera Villa Scassi | Genova | GE | 16149 | Italy |
| Fondazione Toscana G.Monasterio - Ospedale del Cuore | Massa | MS | 54100 | Italy |
| Azienda Ospedaliera di Padova | Padova | PD | 35128 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Marche Nord | Pesaro | PU | 61121 | Italy |
| Fondazione IRCCS Policlinico S.Matteo | Pavia | PV | 27100 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | RE | 43123 | Italy |
| Ospedale di Castelfranco Veneto | Castelfranco Veneto | Treviso | 31033 | Italy |
| Presidio Ospedaliero di Conegliano | Conegliano | Treviso | 31015 | Italy |
| Ospedale di Circolo Fondazione Macchi | Varese | VA | 21100 | Italy |
| Ospedale Sant'Andrea | La Spezia | 19100 | Italy |
| Policlinico Le Scotte | Siena | 53100 | Italy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IMR Evaluation | Assessment of IMR index in coronaries through PressureWire Certus guidewire PressureWire Certus guidewire: Assessment of IMR index in coronaries through PressureWire Certus guidewire |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Systolic Blood Pressure | Normal range = 120-129 mmHg | Mean | Standard Deviation | mmHg |
| ||||||||||||||||
| Diastolic Blood Pressure | Normal range = 80-84 mmHg | Mean | Standard Deviation | mmHg |
| ||||||||||||||||
| Heart Rate | Normal range = 60-100 bpm | Mean | Standard Deviation | bpm (Beats Per Minute) |
| ||||||||||||||||
| Syntax Score (SS) | Measure of complexity grade of coronary artery disease; higher SS values indicate a more complex disease, a greater therapeutic challenge and potentially worse acute and long-term outcomes. SS categorization: score <= 22 -> low; score = 23-32 -> intermediate; score >= 33 -> high. Scale range: min score = 0; max score = 60 | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Infarcted area | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with Hypertension | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with Diabetes | Count of Participants | Participants |
| ||||||||||||||||||
| Parrticipants with Hyperlipidemia and/or Dyslipidemia | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with Renal dysfunction | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with significant alcohol intake | Count of Participants | Participants |
| ||||||||||||||||||
| Smoker | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with history of stroke | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with history of Transient Ischemic Attach (TIA) | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with history of Myocardial Infarction | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with history of Percutaneous Coronary Intervention (PCI) | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with Family history of heart disease | Count of Participants | Participants |
| ||||||||||||||||||
| Participants with history of Heart failure | Count of Participants | Participants |
| ||||||||||||||||||
| Killip class | Higher class means patient more compromise. Class 1: Absence of rales over the lung fields and absence of a third heart sound (S3) Class 2: Rales over 50% or less of the lung fields or the presence of an S3 Class 3: Rales over more than 50% of the lung fields Class 4: Cardiogenic Shock | Count of Participants | Participants |
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| 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 | Composite of: Cardiovascular Death*, Re-myocardial Infarct, Re-hospitalization for Heart Failure (HF) and Congestive Heart Failure (CHF), Resuscitation or ICD Appropriate Shock. | Composite of: cardiovascular death*, re-myocardial infarct, re-hospitalization for heart failure (HF) and Congestive Heart Failure (CHF), resuscitation or ICD appropriate shocK, at 1 year. * = timing of mortality evaluation: once culprit lesion has been evaluated through IMR Composite endpoint was evaluated as time to first event, whichever individual component occurred first. | Posted | Count of Participants | Participants | 1 year |
|
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| |||||||||||||||||||||||||||
| Secondary | New Congestive Heart Failure (CHF) During Index Hospitalization | Count of participants with a new CHF during index hospitalization. Hospital stay expected average = 5-10 days | Participants that had a new congestive heart failure (CHF) during index procedure | Posted | Count of Participants | Participants | At the end of hospital stay |
|
| |||||||||||||||||||||||||||
| Secondary | Left Ventricular (LV) Remodeling | Left Ventricular (LV) remodeling at 1 year; improvement of Ejection Fraction %(EF) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. | Echo data site reported, a complete echo has not been always done during discharge and fup visits. | Posted | Mean | Standard Deviation | % of ejection fraction | 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Left Ventricular (LV) Remodeling | Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Systole Volume (LVESV) and Left Ventricular End Diastole Volume (LVEDV) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. | Echo data site reported, a complete echo has not been always done during discharge and fup visits. | Posted | Mean | Standard Deviation | ml | 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Left Ventricular (LV) Remodeling | Left Ventricular (LV) remodeling at 1 year; improvement of Left Ventricular End Diastole Diameter (LVEDD) and Left Ventricular End Systole Diameter (LVESD) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. | Echo data site reported, a complete echo has not been always done during discharge and fup visits. | Posted | Mean | Standard Deviation | mm | 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Left Ventricular (LV) Remodeling | Left Ventricular (LV) remodeling at 1 year; improvement of 16 segments Wall Motion Score Index (WMSI) assessed by TTE. A TTE evaluation has been done both at discharge and at 1-year fup. 16WMSI = 1 is considered normokinetic; 16WMSI = 1,5 is considered mild hypokinesia; 16WMSI = 2 is considered hypokinesia; 16WMSI = 2,5 is considered severe hypokinesia; 16WMSI = 3 is considered akinetic. Scale range: from 1 to 3 | Echo data site reported, a complete echo has not been always done during discharge and fup visits. | Posted | Mean | Standard Deviation | index | 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Left Ventricular (LV) Remodeling - Mitral Insufficiency | Left Ventricular (LV) remodeling at 1 year; improvement of mitral insufficiency (MI) values assessed by TTE. A TTE evalutation has been done both at discharge and at 1-year fup. Each row reports the number of participants that have that specific grade of mitral insufficiency. Grade = 0 indicates no MI; grade = 1 indicates mild MI; grade = 2 indicates moderate MI; grade = 3 indicates severe MI | Echo data site reported, a complete echo has not been always done during discharge and fup visits | Posted | Count of Participants | Participants | 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Need for New Revascularization | Incidence of new revascularizations at 1 year | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Stent Thrombosis | Incidence of stent thrombosis at 1 year | Posted | Count of Participants | Participants | 1 year |
|
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| |||||||||||||||||||||||||||
| Secondary | Evaluation of a Better Cut-off of IMR Index Based on Primary Endpoints Events | Evaluation of a better cut-off of IMR index based on primary endpoints events. Table below reports the values of ROC curve. | Posted | Number | probability | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Evaluation of Possible Events Predictors | Results of logistic regression model; differences were considered statistically significant when p<0,05. | Posted | Number | correlation coefficient | 1 year |
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|
Adverse event data have been collected over 1 year period of time from primary procedure
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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 | STEMI Patient | STEMI patient treated with primary PCI with IMR evaluation. Study designed with 1 unique group | 5 | 242 | 58 | 242 | 16 | 242 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Angina or atypical chest pain | Cardiac disorders | Systematic Assessment |
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| Asystolia | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Planned ICD implantation for primary disease | Cardiac disorders | Systematic Assessment |
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| COPD reacutization | Cardiac disorders | Systematic Assessment |
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| Effort angina | Cardiac disorders | Systematic Assessment |
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| Heart failure | Cardiac disorders | Systematic Assessment |
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| Iatrogenic sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Coronary revascularization | Cardiac disorders | Systematic Assessment |
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| Planned angiography | Cardiac disorders | Systematic Assessment |
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| Mitral regurgitation | Cardiac disorders | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
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| Pulmonary stasis | Cardiac disorders | Systematic Assessment |
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| Parossistic dyspnoea | Cardiac disorders | Systematic Assessment |
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| Stable angina | Cardiac disorders | Systematic Assessment |
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| Bleeding from duodenal angiodysplasia | Gastrointestinal disorders | Systematic Assessment |
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| Allergic reaction | Immune system disorders | Systematic Assessment |
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| Subdural hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Planned angiography for control | Investigations | Systematic Assessment |
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| Broken femur | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Ischaemic | Nervous system disorders | Systematic Assessment |
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| TIA in left side with right hemiparesis | Nervous system disorders | Systematic Assessment |
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| Stroke | Nervous system disorders | Systematic Assessment |
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| Iatrogenic syncope | Nervous system disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Urinary Sepsi | Renal and urinary disorders | Systematic Assessment |
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| Kidney insufficiency | Renal and urinary disorders | Systematic Assessment |
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| Fever, possible pleuritis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Left pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Lung neoplasia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Intra-stent thrombosis | Vascular disorders | Systematic Assessment |
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| Coronary artery dissection | Vascular disorders | Systematic Assessment |
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| Femoral hematoma | Vascular disorders | Systematic Assessment |
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| Thrombosis of radial right forearm | Vascular disorders | Systematic Assessment |
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| Cardiogenic shock | Vascular disorders | Systematic Assessment |
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| Right femoral region leakage | Vascular disorders | Systematic Assessment |
| ||
| Hypotensive syncope betablocker related | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain | Cardiac disorders | Systematic Assessment |
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| Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Probably neuralgic pain | Nervous system disorders | Systematic Assessment |
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| Lypothymia | Nervous system disorders | Systematic Assessment |
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| Chest pain not coronary related | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cought | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Asymptomatic culprit vessel occlusion founded during staged procedure | Vascular disorders | Systematic Assessment |
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| Acute thrombosis stent | Vascular disorders | Systematic Assessment |
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| Astenia, hypotension | Vascular disorders | Systematic Assessment |
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| Epistaxis | Vascular disorders | Systematic Assessment |
|
Since it is a multicenter study,no results presentation or publication shall be made prior to the communication,presentation or publication to congresses and/or scientific journals without Sponsor consent.Investigator has to provide copy of any proposed Publication&all related materials to Sponsor for consideration at least 30 days prior to the proposed submission date.Sponsor can ask Investigator to refrain from making the Publication for 60 days in order to verify the accuracy of information
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanoni Benedetta, Abbott Clinical Site Lead | Abbott Medical Italia | +39340571064 | benedetta.vanoni@abbott.com |
| Oct 31, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| Circumflex Artery (CX) |
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| Oral treatment |
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| None |
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| None |
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| None |
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| Class II |
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| Class III |
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| Class IV |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Categories |
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| Age |
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| Male |
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| Number of PCIs (PCIs done both during Primary and Staged procedures) |
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| Hypertension |
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| Lipids |
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| Smoking |
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| LVEF (at discharge) |
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| WMSI (at discharge) |
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