BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
Completed · Not applicable
Conditions studied: Myocardial Infarction, Myocardial Infarction, Acute, Myocardial Infarction Old
In brief
The BIO\|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.
Key facts
- Study ID
- NCT02341534
- Run by
- Biotronik SE & Co. KG
- People needed
- 802
- Starts
- 2015-08-07
- Expected to finish
- 2021-11-03
- Last updated by the study team
- 2023-04-13
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient has a history of MI according to guidelines
- CHA2DS2-VASc-Score ≥ 4 in men / ≥ 5 in women
- LVEF > 35 % as estimated within 6 months before enrollment but after conclusion of AMI treatment
- Patient accepts activation of Home Monitoring®
- Patient is able to understand the nature of the clinical study and has provided written informed consent
You may not qualify if…
- Patients with hemorrhagic diathesis
- Permanent oral anticoagulation treatment for atrial fibrillation
- Indication for chronic renal dialysis
- Pacemaker or ICD implanted or indication for implantation
- Parkinson's disease
- Life expectancy < 1 year
- Participation in another interventional clinical Investigation
- Age < 18 years
- Woman who are pregnant or breast feeding
Where it is running
- St. Louis Heart and Vascular — St Louis, Missouri, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Altru Health System — Grand Forks, North Dakota, United States
- Abington Medical Specialists — Abington, Pennsylvania, United States
- Carolina Heart Specialists — Lancaster, South Carolina, United States
- Carolina Cardiology Associates — Rock Hill, South Carolina, United States
- Metro Knoxville HMA LLC — Knoxville, Tennessee, United States
- Lyell McEwin Hospital (LMH) — Elizabeth Vale, South Australia, Australia
- East Metropolitan Health Service Trading AS Royal Perth HOSPITAL — Perth, Western Australia, Australia
- The Canberra Hospital — Canberra, Australia
- Kepler Universitätsklinikum — Linz, Upper Austria, Austria
- OLV Ziekenhuis Aalst — Aalst, Belgium
- Ziekenhuis Oost Limburg Genk (ZOL Genk) — Genk, Belgium
- Nemocnice České Budějovice — České Budějovice, Czechia
- Fakultní nemocnice Olomouc — Olomouc, Czechia
- Institute for Clinical and Experimental Medicine (IKEM) — Prague, Czechia
- Odense University Hospital (OUH) — Odense, Region Syddanmark, Denmark
- Aalborg Universitetshospitel — Aalborg, Denmark
- Århus Universitetshospital — Århus N, Denmark
- Rigshospitalet — Copenhagen, Denmark
- Regionshospitalet Herning — Herning, Denmark
- Sjaellands Universitets Hospital, Roskilde — Roskilde, Denmark
- Regionshospitalet Viborg — Viborg, Denmark
- CHRU de Tours - Hôpital Trousseau — Chambray-lès-Tours, France
- Gateway Cardiology — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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