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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| General Electric | INDUSTRY |
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The purpose of the study is to assess the prevalence and the prognostic value of non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF)>40%.
1000 asymptomatic post-MI patients>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia) will be enrolled.
The patients will be divided into two categories:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-MI patients | Asymptomatic post-MI patients late after MI or 40 days after STEMI-NSTEMI with preserved ejection fraction and absence of active ischemia Programmed ventricular stimulation (PVS) will be performed in high-risk patients based on non-invasive evaluation. ICD implantation will be performed in patients with induced ventricular tachycardia (VT) upon PVS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Programmed ventricular stimulation | Procedure | Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation | The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD | From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup |
| Measure | Description | Time Frame |
|---|---|---|
| Total Mortality | All-cause mortality | From completion of risk stratification to study completion or outcome occurrence (mean 32 months) |
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Inclusion Criteria:
Exclusion Criteria:
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1000 asymptomatic post-MI patients>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia)
The patients will be divided into two categories:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Gatzoulis, MD, PhD | University of Athens, Hippokration Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Cardiology Clinic, Hippokration Hospital | Athens | 11527 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31049557 | Derived | Gatzoulis KA, Tsiachris D, Arsenos P, Antoniou CK, Dilaveris P, Sideris S, Kanoupakis E, Simantirakis E, Korantzopoulos P, Goudevenos I, Flevari P, Iliodromitis E, Sideris A, Vassilikos V, Fragakis N, Trachanas K, Vernardos M, Konstantinou I, Tsimos K, Xenogiannis I, Vlachos K, Saplaouras A, Triantafyllou K, Kallikazaros I, Tousoulis D. Arrhythmic risk stratification in post-myocardial infarction patients with preserved ejection fraction: the PRESERVE EF study. Eur Heart J. 2019 Sep 14;40(35):2940-2949. doi: 10.1093/eurheartj/ehz260. |
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From April 2014 to July 2018, 575 consecutive patients were enrolled in the seven Departments of Cardiology participating in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Risk Group | No Non-Invasive Risk Factors (NIRFs) present - no invasive programmed ventricular stimulation (PVS) performed |
| FG001 | Intermediate Risk Group | At least one NIRF present - noninducible upon programmed ventricular stimulation (PVS) (no sustained ventricular tachyarrhythmia was induced i.e. either with a duration >30seconds or causing hemodynamic instability necessitating termination) |
| FG002 | High Risk Group | At least one NIRF present AND inducible upon PVS (sustained ventricular tachyarrhythmia was induced). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to some patients' refusal to be submitted to invasive programmed ventricular stimulation, 52 patients were unstratifiable (unknown if Group 2 or 3), and thus 371+111+41=523=575-52
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Risk Group | No NIRFs present - no invasive PVS performed |
| BG001 | Intermediate Risk Group | At least one NIRF present - noninducible upon PVS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation | The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD | Posted | Number | participants | From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup |
|
From stratification completion (allocation to one of risk level groups) to adverse event occurrence, or study completion - mean 32 months
Adverse events due to PVS and ICD implantation
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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 | Low Risk Group | No NIRFs present - no invasive PVS performed | 0 |
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Study was not a randomized clinical trial since almost all patients with a per protocol indication received a device, without the presence of a high-risk control group, thus potentially overestimating true arrhythmic risk.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Konstantinos A. Gatzoulis | First Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens | 6944580369 | 0030 | kgatzoul@med.uoa.gr |
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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 | Jan 23, 2019 | Jul 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ICD implantation | Device | ICD implantation in patients with induced VT in programmed ventricular stimulation |
|
| BG002 | High Risk Group | At least one NIRF present AND inducible upon PVS |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Intermediate Risk Group |
At least one NIRF present - noninducible upon PVS |
| OG002 | High Risk Group | At least one NIRF present AND inducible upon PVS. |
|
|
| Secondary | Total Mortality | All-cause mortality | Posted | Count of Participants | Participants | From completion of risk stratification to study completion or outcome occurrence (mean 32 months) |
|
|
|
| 371 |
| 0 |
| 371 |
| 0 |
| 371 |
| EG001 | Intermediate Risk Group | At least one NIRF present - noninducible upon PVS | 4 | 111 | 0 | 111 | 0 | 111 |
| EG002 | High Risk Group | At least one NIRF present AND inducible upon PVS. | 1 | 41 | 0 | 41 | 0 | 41 |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| Male |
|