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Completed

NCT Number: NCT03715790

Improve SCA Bridge Study

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).

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Key information

Conditions

Sudden Cardiac Arrest Acute Myocardial Infarction Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Heart Foundation Hospital and Research Institute, Dhaka, Bangladesh

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria required by local law (e.g. pregnancy, breast feeding etc.)
  • Patient is unable (e.g. mental disorder) or unwilling to be compliant with the responsibilities as specified in the informed consent form.
  • Patient is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader

Treatment and study plan

EP referred group

Behavioral

Referred for sudden cardiac death (SCD) risk stratification and management

Non-Referred group

Behavioral

Not referred for sudden cardiac death (SCD) risk stratification and management.

Primary outcomes

  1. Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management

    Time frame: 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 outcomes

  1. Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI

    Time frame: 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.

  2. Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI.

    Time frame: 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.

  3. Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD

    Time frame: 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:

    • a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being lower or equal than 40%.

    >

    • ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities as measured by ECGs.

    >

    • 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.

  4. Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality

    Time frame: 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.

  5. Evolution of the Ejection Fraction Over the Immediate Period of Post MI

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Improve Sudden Cardiac Arrest (SCA) Bridge Study

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2018
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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