Acute Myocardial Infarction, Sudden Cardiac Arrest
Conditions
Brief summary
The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase (≥40-90 days post-acute MI).
Detailed description
To determine how many patients are referred for sudden cardiac death (SCD) risk stratification and management, indicated for implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant, and how many receive such devices within 12 months of experiencing an MI.
Interventions
BEHAVIORALEP referred group
Referred for sudden cardiac death (SCD) risk stratification and management
BEHAVIORALNon-Referred group
Not referred for sudden cardiac death (SCD) risk stratification and management.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 and above (or meet age requirements per local law) * Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI) ≤ 30 days of study enrollment and have a LVEF \<50% measurement ≤ 14 days post-acute MI * Willing and able to give valid Informed Consent
Exclusion criteria
* Patient has previously received or currently implanted with an ICD or CRT-D * Patient has any contraindication for ICD/CRT-D * Patient has a life expectancy of less than 12 months * Patient who has had an EP referral within the last 12 months * Any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management | 3-months post-MI to 12-months post-MI | The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of referred and not referred groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI | 3-months post-MI to 12-months post-MI | The numerator for this endpoint will be the number of subjects who were indicated for an ICD/CRT-D device during any of the three follow-up visits. The denominator will be the number of subjects who completed a 3-month follow-up visit. While the participant study flow is composed of referred and not referred groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the referred and not referred groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint. |
| Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI. | 3-months post-MI to 12-months post-MI | The numerator for this endpoint will be the number of subjects who received an ICD/CRT-D device during any of the three follow-up visits. The denominator for this endpoint will be the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of referred and not referred groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the referred and not referred groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint. |
| Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | 3-months post-MI to 12-months post-MI | The outcome measure will be the percentage of patients with ICD indication, who were not referred, refused referral or refused implant. The denominator will count all patients with at least one of the below: 1. a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being lower or equal than 40%. \> 2. ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities as measured by ECGs. \> 3. unexplained syncope, clinically significant palpitations or symptomatic bradycardia as assessed by the physician. \> The numerator will count the patients included in the denominator who were not referred, refused referral or refused implant of an ICD/CRT-D. While the participant study flow is composed of referred and not referred groups, these groups are simply the referral process results in the single arm of enrolled patients, with analysis performed within this arm. No hypotheses were tested for this endpoint. |
| Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality | Enrollment to 12-months post-MI | The numerator for this endpoint will be the number of patients who experience cardiovascular mortality. The denominator will be the number of patients enrolled in the study. No hypotheses were tested for this endpoint. |
| Evolution of the Ejection Fraction Over the Immediate Period of Post MI | Enrollment to 3-months post-MI | The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) and chronically (40-90 days). The acute measurement will occur over all 1491 subjects assessed at baseline, while the chronic assessment will be measured over the 1046 subjects with a 3-month LVEF assessment. This outcome will compare the average LVEF, by percent, between these two phases. No hypotheses were tested for this endpoint. |
Countries
Bangladesh, Brunei, China, Egypt, India, Indonesia, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Tunisia
Participant flow
Pre-assignment details
While the study objective was to categorize patients into those who met referral criteria and those who did not, those two groups were not, strictly speaking, considered to be treatment arms. Rather, subjects in the single enrolled patients arm could, by meeting the required criteria at any of the three follow-up evaluations, be reported in the referral group. Thus the two groups were the result of the collective referral assessments and not separate study arms with a subsequent study flow.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Subjects Subjects who were enrolled in the Improve SCA Bridge Study and were not excluded due to not meeting inclusion/exclusion criteria | 1,491 |
| Total | 1,491 |
Baseline characteristics
| Characteristic | Enrolled Subjects | — |
|---|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Bangladesh | 80 participants | — |
| Region of Enrollment Brunei | 30 participants | — |
| Region of Enrollment China | 394 participants | — |
| Region of Enrollment Egypt | 15 participants | — |
| Region of Enrollment India | 267 participants | — |
| Region of Enrollment Indonesia | 38 participants | — |
| Region of Enrollment Malaysia | 86 participants | — |
| Region of Enrollment Pakistan | 50 participants | — |
| Region of Enrollment Philippines | 1 participants | — |
| Region of Enrollment Saudi Arabia | 70 participants | — |
| Region of Enrollment Singapore | 19 participants | — |
| Region of Enrollment South Africa | 12 participants | — |
| Region of Enrollment South Korea | 237 participants | — |
| Region of Enrollment Taiwan | 120 participants | — |
| Region of Enrollment Thailand | 22 participants | — |
| Region of Enrollment Tunisia | 50 participants | — |
| Sex: Female, Male Female | 263 Participants | — |
| Sex: Female, Male Male | 1228 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 88 / 1,491 |
| other Total, other adverse events | 18 / 1,491 |
| serious Total, serious adverse events | 180 / 1,491 |
Outcome results
Primary
Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management
The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of referred and not referred groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint.
Time frame: 3-months post-MI to 12-months post-MI
Population: Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Referred Subjects | Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management | 236 Participants |
| Not Referred Subjects | Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management | 934 Participants |
Secondary
Evolution of the Ejection Fraction Over the Immediate Period of Post MI
The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) and chronically (40-90 days). The acute measurement will occur over all 1491 subjects assessed at baseline, while the chronic assessment will be measured over the 1046 subjects with a 3-month LVEF assessment. This outcome will compare the average LVEF, by percent, between these two phases. No hypotheses were tested for this endpoint.
Time frame: Enrollment to 3-months post-MI
Population: Acute LVEF measurements occurred at baseline on 1491 subjects. Chronic LVEF measurements were collected at the 3-month follow up on 1046 subjects (104 subjects were exited before the 3-month follow up, and 341 subjects did not have their LVEF measurement taken at the 3-month follow up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Referred Subjects | Evolution of the Ejection Fraction Over the Immediate Period of Post MI | Chronic | 46.3 Percentage of LV stroke volume | Standard Deviation 10.3 |
| Referred Subjects | Evolution of the Ejection Fraction Over the Immediate Period of Post MI | Acute | 39.8 Percentage of LV stroke volume | Standard Deviation 6.8 |
Secondary
Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD
The outcome measure will be the percentage of patients with ICD indication, who were not referred, refused referral or refused implant. The denominator will count all patients with at least one of the below: 1. a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being lower or equal than 40%. \> 2. ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities as measured by ECGs. \> 3. unexplained syncope, clinically significant palpitations or symptomatic bradycardia as assessed by the physician. \> The numerator will count the patients included in the denominator who were not referred, refused referral or refused implant of an ICD/CRT-D. While the participant study flow is composed of referred and not referred groups, these groups are simply the referral process results in the single arm of enrolled patients, with analysis performed within this arm. No hypotheses were tested for this endpoint.
Time frame: 3-months post-MI to 12-months post-MI
Population: Enrolled patients who, at the 3-month visit, met the criteria for referral for SCD risk stratification. These criteria include a reduced ejection fraction less than or equal to 40%, ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities, or unexplained syncope, clinically significant palpitations or symptomatic bradycardia.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Referred Subjects | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Number of patients who who were not referred, refused referral or refused implant of an ICD/CRT-D | 162 Participants |
| Referred Subjects | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Number of patients not referred due to the patient deemed referral not necessary. | 21 Participants |
| Referred Subjects | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Number of patients not referred due to the patient was asymptomatic. | 42 Participants |
| Referred Subjects | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Number of patients not referred due to the physician preferred continuing with medication. | 75 Participants |
| Referred Subjects | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Number of patients who refused implant due to patient does not want risk associated with implant. | 40 Participants |
| Referred Subjects | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Number of patients who refused implant due to patient does not believe in benefit of ICD/CRT-D. | 36 Participants |
| Referred Subjects | Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD | Number of patients who refused implant due to patient unable to pay for device. | 62 Participants |
Secondary
Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI
The numerator for this endpoint will be the number of subjects who were indicated for an ICD/CRT-D device during any of the three follow-up visits. The denominator will be the number of subjects who completed a 3-month follow-up visit. While the participant study flow is composed of referred and not referred groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the referred and not referred groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint.
Time frame: 3-months post-MI to 12-months post-MI
Population: Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Referred Subjects | Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI | 127 Participants |
Secondary
Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality
The numerator for this endpoint will be the number of patients who experience cardiovascular mortality. The denominator will be the number of patients enrolled in the study. No hypotheses were tested for this endpoint.
Time frame: Enrollment to 12-months post-MI
Population: Enrolled subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Referred Subjects | Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality | 29 Participants |
Secondary
Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI.
The numerator for this endpoint will be the number of subjects who received an ICD/CRT-D device during any of the three follow-up visits. The denominator for this endpoint will be the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of referred and not referred groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this single arm. The analysis cannot be performed within the referred and not referred groups as patients not referred are not eligible for the secondary endpoints involving device indication or implant. No hypotheses were tested for this endpoint.
Time frame: 3-months post-MI to 12-months post-MI
Population: Enrolled subjects who were evaluated at 3-month follow up to determine if they met referral criteria or did not meet referral criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Referred Subjects | Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI. | 18 Participants |