NCT03715790

Improve SCA Bridge Study

Completed Results posted Last updated 16 January 2024

What this trial tests

trial testing EP referred group in Sudden Cardiac Arrest in 1,491 participants. Completed in 27 May 2021.

Timeline

2 November 2018

Primary endpoint
16 April 2021

27 May 2021

Quick facts

Lead sponsor	Medtronic Cardiac Rhythm and Heart Failure
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,491
Start date	2 November 2018
Primary completion	16 April 2021
Estimated completion	27 May 2021
Sites	52 locations across Tunisia, Pakistan, South Africa, Malaysia, Taiwan, Saudi Arabia, Indonesia, South Korea

Drugs / interventions tested

• EP referred group
• Non-Referred group

Conditions studied

• Sudden Cardiac Arrest — all drugs for Sudden Cardiac Arrest →
• Acute Myocardial Infarction — all drugs for Acute Myocardial Infarction →

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

Adults 18 to 90, any sex, with Sudden Cardiac Arrest or Acute Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Referred Subjects	236
Not Referred Subjects	934

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

Group	Value	95% CI
Post-acute MI Subjects	127

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

Group	Value	95% CI
Post-acute MI Subjects	18

Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD Secondary · 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 numerato

Number of patients who who were not referred, refused referral or refused implant of an ICD/CRT-D

Group	Value	95% CI
Subjects Who Met Referral Criteria	162

Number of patients not referred due to "the patient deemed referral not necessary".

Group	Value	95% CI
Subjects Who Met Referral Criteria	21

Number of patients not referred due to "the patient was asymptomatic".

Group	Value	95% CI
Subjects Who Met Referral Criteria	42

Number of patients not referred due to "the physician preferred continuing with medication".

Group	Value	95% CI
Subjects Who Met Referral Criteria	75

Number of patients who refused implant due to "patient does not want risk associated with implant".

Group	Value	95% CI
Subjects Who Met Referral Criteria	40

Number of patients who refused implant due to "patient does not believe in benefit of ICD/CRT-D".

Group	Value	95% CI
Subjects Who Met Referral Criteria	36

Number of patients who refused implant due to "patient unable to pay for device".

Group	Value	95% CI
Subjects Who Met Referral Criteria	62

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

Group	Value	95% CI
Enrolled Subjects	29

Evolution of the Ejection Fraction Over the Immediate Period of Post MI Secondary · 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.

Acute

Group	Value	95% CI
Enrolled Subjects	39.8	± 6.8

Chronic

Group	Value	95% CI
Enrolled Subjects	46.3	± 10.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected starting at baseline through 12-month follow up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Enrolled Subjects

Serious: 180/1491 (12%)

Deaths: 88/1491

Serious adverse events (56 terms)

Reaction	System	Enrolled Subjects
Cardiac Failure Acute	Cardiac disorders	—
Acute Myocardial Infarction	Cardiac disorders	—
Death	General disorders	—
Coronary Artery Disease	Cardiac disorders	—
Sudden Cardiac Death	General disorders	—
Cardiac Failure	Cardiac disorders	—
Acute Coronary Syndrome	Cardiac disorders	—
Angina Pectoris	Cardiac disorders	—
Cardiac Arrest	Cardiac disorders	—
Acute Left Ventricular Failure	Cardiac disorders	—
Arteriosclerosis Coronary Artery	Cardiac disorders	—
Cardiac Failure Congestive	Cardiac disorders	—
Angina Unstable	Cardiac disorders	—
Cardio-Respiratory Arrest	Cardiac disorders	—
Cardiogenic Shock	Cardiac disorders	—
Ventricular Fibrillation	Cardiac disorders	—
Cerebrovascular Accident	Nervous system disorders	—
Cardiac Failure Chronic	Cardiac disorders	—
Intracardiac Thrombus	Cardiac disorders	—
Gastrointestinal Haemorrhage	Gastrointestinal disorders	—
Multiple Organ Dysfunction Syndrome	General disorders	—
Cerebral Infarction	Nervous system disorders	—
Anaemia	Blood and lymphatic system disorders	—
Arrhythmia	Cardiac disorders	—
Atrial Fibrillation	Cardiac disorders	—

Other adverse events (10 terms — click to expand)

Reaction	System	Enrolled Subjects
Angina Pectoris	Cardiac disorders	—
Cardiac Ventricular Thrombosis	Cardiac disorders	—
Arteriosclerosis Coronary Artery	Cardiac disorders	—
Atrioventricular Block	Cardiac disorders	—
Cardiac Aneurysm	Cardiac disorders	—
Dizziness Postural	Nervous system disorders	—
Syncope	Nervous system disorders	—
Transient Ischaemic Attack	Nervous system disorders	—
Acute Kidney Injury	Renal and urinary disorders	—
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Cardiac Failure Acute, Acute Myocardial Infarction, Death, Coronary Artery Disease, Sudden Cardiac Death, Cardiac Failure, Acute Coronary Syndrome, Angina Pectoris.

Data from ClinicalTrials.gov NCT03715790 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improve the Prevention of Sudden Cardiac Arrest in Patients With Post-Acute Myocardial Infarction.
   Zhang S, Chen WJ, Sankardas MA, Ahmed WH, et al · · 2022 · cited 5× · PMID 36518723 · DOI 10.1016/j.jacasi.2022.06.006