Last reviewed · How we verify
Home Telemonitoring In Patients After Myocardial Infarction
NA trial testing SmartHeart Device in Myocardial Infarction in 195 participants. Completed in 2 May 2024.
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 195 |
| Start date | 14 October 2020 |
| Primary completion | 2 May 2024 |
| Estimated completion | 2 May 2024 |
| Sites | 1 location across United States |
Mayo Clinic
18 and older, any sex, with Myocardial Infarction or Heart Attack. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of emergency room visits over a period of 90 days after an index hospitalization for an acute myocardial infarction
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 40 | |
| SmartHeart Device Group | 33 |
Number of re-hospitalizations over a period of 90 days after an index hospitalization for an acute myocardial infarction
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 9 | |
| SmartHeart Device Group | 11 |
Number of deaths over a period of 90 days after an index hospitalization for an acute myocardial infarction
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 4 | |
| SmartHeart Device Group | 3 |
Number of major adverse cardiovascular events including cardiovascular death and hospitalization for myocardial infarction, unstable angina, repeat revascularization, heart failure, stroke, arrhythmias, and cardiac arrest over a period of 90 days after an index hospitalization for an acute myocardial infarction
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 1 | |
| SmartHeart Device Group | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 1 | |
| SmartHeart Device Group | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 0 | |
| SmartHeart Device Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 0 | |
| SmartHeart Device Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 0 | |
| SmartHeart Device Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 0 | |
| SmartHeart Device Group | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Control (Standard Treatment) Group | 1 | |
| SmartHeart Device Group | 2 |
Time frame: Adverse events were collected from patient consent through study completion, approximately 90 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Control (Standard Treatmen… | SmartHeart Device Group |
|---|---|---|---|
| Hospitalization for Myocardial Infarction | Cardiac disorders | — | — |
| Arrhythmias | Cardiac disorders | — | — |
| Cardiac Arrest | Cardiac disorders | — | — |
| Heart Failure | Cardiac disorders | — | — |
| Repeat Revascularization | Cardiac disorders | — | — |
| Unstable Angina | Cardiac disorders | — | — |
| Reaction | System | Control (Standard Treatmen… | SmartHeart Device Group |
|---|---|---|---|
| Chest Pain | Cardiac disorders | — | — |
| Neck Pain | Musculoskeletal and connective tissue disorders | — | — |
| Non-Cardiac Chest Pain | General disorders | — | — |
| Palpitations | Cardiac disorders | — | — |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | — | — |
| Cellulitis | Infections and infestations | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Elevated Blood Pressure | Surgical and medical procedures | — | — |
| Mechanical Fall | Injury, poisoning and procedural complications | — | — |
| Rapid Heart Rate | Cardiac disorders | — | — |
| Peripheral Edema | General disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Scalp Laceration | Injury, poisoning and procedural complications | — | — |
| Pneumonia | Infections and infestations | — | — |
| General Weakness | General disorders | — | — |
| Angioedema | Immune system disorders | — | — |
| Diverticulitis | Gastrointestinal disorders | — | — |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | — | — |
| Numbness and Tingling in Extremity | Nervous system disorders | — | — |
| Pain and Swelling in Hand | General disorders | — | — |
| Bleeding | Injury, poisoning and procedural complications | — | — |
| Dizziness | Nervous system disorders | — | — |
| Gastrointestional Hemorrhage | Gastrointestinal disorders | — | — |
| Idiopathic Generalized Epilepsy | Nervous system disorders | — | — |
| Fibula Fracture | Injury, poisoning and procedural complications | — | — |
| Pelvic Fracture | Injury, poisoning and procedural complications | — | — |
| Swelling over Left Supraorbital Area | Injury, poisoning and procedural complications | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — |
| Malignant Neoplasm of Colon | Gastrointestinal disorders | — | — |
| Allergic Reaction | Immune system disorders | — | — |
| Supraventricular Tachycardia | Cardiac disorders | — | — |
| Coronary Artery Disease | Cardiac disorders | — | — |
| Syncope | Nervous system disorders | — | — |
Most-reported serious reactions: Hospitalization for Myocardial Infarction, Arrhythmias, Cardiac Arrest, Heart Failure, Repeat Revascularization, Unstable Angina.
Data from ClinicalTrials.gov NCT04664881 adverse events section.
This study is being done to determine if taking an electrocardiogram (ECG) by a portable device (SmartHeart) followed by a phone call will improve patient outcomes by early recognition of abnormalities and decrease emergency room visits and hospital readmissions compared to standard therapy alone.
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04664881.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing