Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| REF/2013/10/005823 | Other Identifier | Clinical Trial Registry - India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the INSPIRE-ELR study is to characterize arrhythmias in post MI low EF (≤35%) patients in the acute phase (at discharge from hospital after index MI) and chronic phase (at 8-10 weeks after index MI) and to correlate with patients at high risk of all-cause mortality or sudden cardiac death (SCD) at 1 year.
The study is a prospective, multi-center, interventional, non-randomized study enrolling post MI low left ventricular ejection fraction (LVEF ≤35%) patients prior to or at discharge from the hospital after index MI as defined in the inclusion criteria. Prior to initiating any study specific procedures, patients needs to provide his/her consent by signing and dating an informed consent form. Inclusion/Exclusion criteria will be evaluated and the patients' medical history and baseline information will be collected. Seven days ELR monitoring will be done at discharge and at chronic phase after index MI. At 6 and 9 months telephone follow-up will be done to evaluate the health status, if there will be no in-office visit planned. At 12 months there will be a scheduled in-office visit conducted to collect the health status. All the patients will be followed-up by telephone (health status) at study end (when the last patient completed the 12 month follow-up)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| External Loop Recorder | Other | This is a non-randomized study. All the patients will be enrolled will received the ELR system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Loop Recorder | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI | Post MI mortality is higher in India than in the US and Western Europe. The hypothesis of the INSPIRE-ELR study was that occurrence of arrhythmias in the acute phase of MI will identify patients at highest risk and we evaluated the percentage clinical signification arrhythmias captured through the ELR post MI in acute phase | 7 days post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year | Analysis included all patients that completed the acute monitoring period. Based on the arrhythmias detected during the acute ELR monitoring period, patients were classified as "with arrhythmia" when during the ELR monitoring period there is any episode of ELR monitored events listed. All other patients are classified "without arrhythmia". Mortality rates after the monitoring period was estimated for both groups. |
Not provided
Patients must meet all of the below criteria to be eligible for the study:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medanta - The Medicity | Gurgaon | Haryana | 122001 | India |
The first patient was enrolled on April 29, 2014. Enrollment continued until the 250th patient was enrolled on January 31, 2016. out of 250, patients, there were 233 patients in the analysis cohort, with at least 72 hours of monitoring documented in the ELR device data or a clinically significant arrhythmia in the first 72 hours of monitoring.
The study enrolled acute post MI patients with a reduced LVEF (≤35%) one day before or on the day of discharge from hospital after index MI. There is no control group in this study. The study was conducted in India and in multi specialty hospitals
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | External Loop Recorder (Single Arm) | This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder) After enrollment in the study the following visits are scheduled:
|
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 Months |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The baseline cohort consists of 250 patients and the analysis cohort of 233. There were 17 patients excluded from the analysis because they were not fulfilling the required criteria of analysis as per the protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | External Loop Recorder (Single Arm) | This is a non-randomized study. All the patients who were enrolled received the ELR system. (External Loop Recorder) After enrollment in the study the following visits are scheduled:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 1 patient was excluded due to LVEF >35% which is the exclusion criteria | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | one patient was excluded due to LVEF>35 which is the exclusion criteria | 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 |
| ||||||||||||||||||
| Ejection Fraction | The baseline cohort consists of 249 patients and the analysis cohort of 233. | Mean | Standard Deviation | % Ejection Fraction |
|
| 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 | The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI | Post MI mortality is higher in India than in the US and Western Europe. The hypothesis of the INSPIRE-ELR study was that occurrence of arrhythmias in the acute phase of MI will identify patients at highest risk and we evaluated the percentage clinical signification arrhythmias captured through the ELR post MI in acute phase | Posted | Number | 95% Confidence Interval | percentage of analyzed population | 7 days post discharge |
|
|
| ||||||||||||||||||||||||||
| Secondary | Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year | Analysis included all patients that completed the acute monitoring period. Based on the arrhythmias detected during the acute ELR monitoring period, patients were classified as "with arrhythmia" when during the ELR monitoring period there is any episode of ELR monitored events listed. All other patients are classified "without arrhythmia". Mortality rates after the monitoring period was estimated for both groups. | There were total 28 deaths reported | Posted | Number | 95% Confidence Interval | percentage of Mortality | 12 Months |
|
|
All safety events were collected once the enrollment started and till the end of patient follow-ups during the period of 3 years
As per the study protocol Deaths and Cardiovascular Related Serious Adverse Events were collected
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | External Loop Recorder (Single Arm) | For this study, only Deaths and Cardiovascular Related Serious Adverse Events were collected. There were in total 28 deaths and 49 SAEs reported. No system or procedure related SAE were reported | 28 | 249 | 49 | 249 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Systematic Assessment | Cardiac arrest |
| |
| Acute left ventricular failure | Cardiac disorders | Systematic Assessment | Acute left ventricular failure |
| |
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment | Cardiac failure congestive |
| |
| Coronary artery disease | Cardiac disorders | Systematic Assessment | Coronary artery disease |
| |
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment | Acute myocardial infarction |
| |
| Ventricular tachyarrhythmia | Cardiac disorders | Systematic Assessment | Ventricular tachyarrhythmia |
| |
| Ventricular tachycardia | Cardiac disorders | Systematic Assessment | Ventricular tachycardia |
| |
| Angina pectoris | Cardiac disorders | Systematic Assessment | Angina pectoris |
| |
| Angina unstable | Cardiac disorders | Systematic Assessment | Angina unstable |
| |
| Atrial fibrillation | Cardiac disorders | Systematic Assessment | Atrial fibrillation |
| |
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment | Atrioventricular block complete |
| |
| Cardiac failure | Cardiac disorders | Systematic Assessment | Cardiac failure |
| |
| Cardiac failure acute | Cardiac disorders | Systematic Assessment | Cardiac failure acute |
| |
| Left ventricular dysfunction | Cardiac disorders | Systematic Assessment | Left ventricular dysfunction |
| |
| Left ventricular failure | Cardiac disorders | Systematic Assessment | Left ventricular failure |
| |
| Death | General disorders | Systematic Assessment | Death |
| |
| Unevaluable event | General disorders | Systematic Assessment | Unevaluable event |
| |
| Chest discomfort | General disorders | Systematic Assessment | Chest discomfort |
| |
| Multi-organ failure | General disorders | Systematic Assessment | Multi-organ failure |
| |
| Sudden cardiac death | General disorders | Systematic Assessment | Sudden cardiac death |
| |
| Vascular stent restenosis | General disorders | Systematic Assessment | Vascular stent restenosis |
| |
| Cerebral infarction | Nervous system disorders | Systematic Assessment | Cerebral infarction |
| |
| Cerebrovascular disorder | Nervous system disorders | Systematic Assessment | Cerebrovascular disorder |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dyspnoea |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Acute pulmonary oedema |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dyspnoea exertional |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hypoxia |
| |
| Aortic stenosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Aortic stenosis |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinay Rajan Ph.D | India Medtronic Pvt. Ltd. | +91 22.3307.4700 | vinay.rajan@medtronic.com |
| ID | Term |
|---|---|
| D009079 | Mucociliary Clearance |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|