Acute Myocardial Infarction Clinical Trial
— SwissheartOfficial title:
SWISSHEART: Prediction and Progression of Heart Failure in Switzerland
Verified date | December 2022 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A retrospective cohort study will be conducted on patients who were hospitalized at the University Hospital Basel (USB), University Hospital Bern (Inselspital), University Hospital Geneva (HUG) and the University Hospital Zurich (USZ) with the diagnosis of AMI and/or AHF. Baseline data will be collected in the hospital during treatment will be complemented by a short outcome evaluation.
Status | Active, not recruiting |
Enrollment | 8000 |
Est. completion date | March 3, 2023 |
Est. primary completion date | March 3, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Female or male patients, age > 18 years 2. Hospitalized with a primary diagnosis of AMI a) ST-segment elevation Myocardial Infarction (STEMI) and Non-STEMI (NSTEMI) have to fulfil the 4th universal definition of myocardial infarction. - Acute myocardial injury with dynamic cardiac troponin (cTn) changes (at least one value above 99th per-centile URL) AND - At least ONE of the following: - Symptoms of myocardial ischemia - New ischemic ECG changes or new pathological Q waves - Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality consistent with ischemic etiology - Intracoronary thrombus on angiography (or autopsy) AND/OR 3. Hospitalization with a primary diagnosis of AHF based on the following criteria: 1. Symptoms: progressive dyspnoea, orthopnoea, paroxysmal nocturnal dyspnoea, AND/OR progressive peripheral oedema, weight gain. AND at least TWO of the following: 2. Signs: basal pulmonary rales AND/OR peripheral oedema, jugular vein dilatation OR 3. N-terminal prohormone of brain natriuretic peptide (NT-proBNP) within 24 hours >450 pg/ml if age <50 years, >900 pg/ml if age 50-75 years, >1800 pg/ml if age >75 years) OR BNP >400 pg/ml. Cut-offs need to be reduced by 50% in case of severe obesity (BMI >35) OR 4. Treatment of AHF within 24 h using the following drugs i) increased diuretics. iv furosemide or increased po furosemide or torasemide ii) inotropes (dobutamine, dopamine, levosimendan, milrinone) iii) i.v. or s.l. vasodilators (nitroglycerine, isosorbide dinitrate) iv) vasopressors (norepinephrine) OR e) Echocardiographic features (within 72 hours) -- automated TTE downloads left ventricular ejection fraction (LVEF) <40% or estimated pulmonary artery systolic pressure (PASP) >40 mmHg or increased estimated right atrium pressure (RA) pressure above 10 mmHg (VCI size / resp. motion) For the control cohort, the inclusion criteria are: 1. Female or male patients, age > 18 years 2. ECG and TTE recording performed within 5 days of each other 3. TTE is labelled as "normal". Exclusion Criteria: If a subject fulfills the following exclusion criteria, he/she may not be included: Existence of a documented statement of the patient against the use of his/her clinical data for research purposes. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel | |
Switzerland | University Hospital, Bern | Bern | |
Switzerland | University Hospital, Geneva | Geneva | |
Switzerland | University Hospital, Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | ETH Zurich, University Hospital, Basel, Switzerland, University Hospital, Geneva, University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with major adverse cardiac events (MACE) until March 2023 | MACE is composed of
All-cause death Cardiovascular Death Acute myocardial infarction Hospitalization for heart failure |
up to 3.5 years after last patient inclusion |
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