Coronary Artery Disease Clinical Trial
— DANSPOTOfficial title:
A Randomized Clinical Trial (RCT) of Population and Sex-specific Troponin Cutoffs for Ruling Out Acute Myocardial Infarction - The Danish Study of Population and Sex-Specific Cutoffs of Troponin
Acute myocardial infarction (MI) is defined as a rise and/or fall in cardiac troponins (cTn) with at least one value above the 99th percentile upper reference limit (URL) in the context of symptoms or clinical evidence of myocardial ischemia. The URL is based on measurements in a healthy reference population. Currently, a sex-uniform manufacturer provided 99th percentile URL of troponin is utilized at Danish hospitals as a diagnostic cutoff for acute MI for both men and women. Reportedly, healthy men have twofold the troponin level compared to healthy women, suggesting that the use of a uniform URL for troponins may lead to the under-diagnostication of acute MI in women and potentially over-diagnostication in men. The purpose of the DANSPOT study is to evaluate the clinical effect on diagnosis, treatment and outcomes in men and women presenting with acute MI of implementing international guidelines recommendations of sex-specific 99th percentile URLs for troponin into clinical practice. First, to determine the sex-specific 99th percentile URLs of troponins based on a healthy Danish reference population, blood samples from Danish blood donors, were analyzed using one troponin T assay and four troponin I assays. Second, the DANSPOT study is a nationwide cluster-randomized trial with "stepped-wedge" design with participation of all 22 Danish hospital laboratories and associated departments of cardiology. With one-month intervals, each of 22 centers are randomized to shift from the presently applied uniform 99th percentile URL of troponin to our newly determined population and sex-specific 99th percentiles URLs. Each patient is followed in Danish registries for 12 months after first admission. The hypothesis of the DANSPOT study is that implementation of population and sex-specific 99th URLs for troponin, will ensure that the right patients receive the right treatment. The investigators expect to detect significantly more women with acute MI, theoretically resulting in a more accurate diagnosis and treatment of women and men with acute MI.
Status | Recruiting |
Enrollment | 7500 |
Est. completion date | February 28, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria for the primary cohort: The primary cohort will include the women and men who are expected to be most significantly impacted by the intervention, and this group is specifically defined by 1. Presenting complaints suggestive of ACS 2. At least one cTn measurement within 24 hours of admission 3. A peak cTn value between the current sex-uniform manufacturer-derived 99th percentile URL and the novel sex-and population-specific 99th percentile URLs for women and men. Presenting complaints suggestive of ACS will be identified in hospital records by the following presenting complaints of "chest pain" (DR074), "angina pectoris" (DI20) and "myocardial infarction" (DI21), "abdominal and pelvic pain" (DR10), "pain in the throat and chest" (DR07), "dyspnea" (DR060), "reflux" (DK21) and "observation due to suspicion of another cardiovascular disorder" (DZ035). Study participants are included at their index admission, and subsequent admissions are evaluated in follow up analyses. Exclusion criteria: - Age < 18 years - Patients with discharge diagnoses with conditions like pericarditis, myocarditis, endocarditis, cardiomyopathy, valve disease, arrhythmia, heart failure, pulmonary embolism, digestive system diseases, diseases of the urinary and reproductive organs, and diseases of bones, muscles, and connective tissue, and no discharge diagnosis of myocardial infarction or angina pectoris The initial month following the implementation of the new sex-specific 99th percentile URLs will be excluded from consideration, as it will be seen as an adjustment period. Consequently, the intervention period will be extended by one month. |
Country | Name | City | State |
---|---|---|---|
Denmark | Hospital of Southern Jutland | Aabenraa | |
Denmark | Aalborg University Hospital | Aalborg | |
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Bispebjerg & Frederiksberg Hospital | Bispebjerg | |
Denmark | Rigshospitalet (Blegdamsvej) | Copenhagen Ø | |
Denmark | Sydvestjysk Sygehus | Esbjerg | |
Denmark | Glostrup University Hospital | Glostrup | |
Denmark | Gødstrup Regional Hospital | Gødstrup | |
Denmark | Herlev & Gentofte Hospital | Herlev | |
Denmark | C Torp-Pedersen | Hillerød | |
Denmark | North Denmark Regional Hospital | Hjørring | |
Denmark | Holbaek Sygehus | Holbæk | |
Denmark | Horsens Hospital | Horsens | |
Denmark | Amager & Hvidovre Hospital | Hvidovre | |
Denmark | Zealand University Hospital | Køge | |
Denmark | Sygehus Lillebælt (Kolding Sygehus & Vejle Sygehus) | Kolding | |
Denmark | Nykøbing Falster County Hospital | Nykøbing Falster | |
Denmark | Odense University Hospital | Odense | |
Denmark | Randers Regional Hospital | Randers | |
Denmark | Slagelse Sygehus | Slagelse | |
Denmark | Svendborg Hospital | Svendborg | |
Denmark | Central Jutland Regional Hospital (Viborg Hospital & Silkeborg Hospital) | Viborg |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital | Aalborg University Hospital, Aarhus University Hospital, Amager Hospital, Bispebjerg Hospital, Central Jutland Regional Hospital, Glostrup University Hospital, Copenhagen, Gødstrup Hospital, Herlev and Gentofte Hospital, Holbaek Sygehus, Horsens Hospital, Hospital of Southern Jutland, Hvidovre University Hospital, Kolding Sygehus, Nordsjaellands Hospital, North Denmark Regional Hospital, Nykøbing Falster County Hospital, Odense University Hospital, Randers Regional Hospital, Rigshospitalet, Denmark, Slagelse Sygehus, Svendborg Hospital, Sydvestjysk Sygehus, Vejle Hospital, Zealand University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A composite of myocardial infarction, unplanned revascularisation (after index admission) or all cause mortality within 1 year of first admission for the primary cohort. | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period.
Primary cohort is defined as the cohort of women and men with suspected acute coronary syndrome (ACS) with at least two cTn measurements within 24 hours with a maximal cTn level between the current sex-uniform manufacturer-derived 99th percentiles of cTn and the newly defined sex-specific 99th percentiles for women and men. |
12 months after index admission | |
Secondary | Number of women with coronary events in the primary cohort (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period.
Primary cohort is defined as the cohort of women and men with suspected acute coronary syndrome (ACS) with at least two cTn measurements within 24 hours with a maximal cTn level between the current sex-uniform manufacturer-derived 99th percentiles of cTn and the newly defined sex-specific 99th percentiles for women and men. Coronary events are defined as the prevalence of cardiovascular death, myocardial infarction or unplanned revascularisation (after index admission) within 1 year of first admission. |
12 months after index admission | |
Secondary | Number of men with coronary events in the primary cohort (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period.
Primary cohort is defined as the cohort of women and men with suspected acute coronary syndrome (ACS) with at least two cTn measurements within 24 hours with a maximal cTn level between the current sex-uniform manufacturer-derived 99th percentiles of cTn and the newly defined sex-specific 99th percentiles for women and men. Coronary events are defined as the prevalence of cardiovascular death, myocardial infarction or unplanned revascularisation (after index admission) within 1 year of first admission. |
12 months after index admission | |
Secondary | Number of women and men with coronary events in the primary cohort (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period.
Primary cohort is defined as the cohort of women and men with suspected acute coronary syndrome (ACS) with at least two cTn measurements within 24 hours with a maximal cTn level between the current sex-uniform manufacturer-derived 99th percentiles of cTn and the newly defined sex-specific 99th percentiles for women and men. Coronary events are defined as the prevalence of cardiovascular death, myocardial infarction or unplanned revascularisation (after index admission) within 1 year of first admission. |
12 months after index admission | |
Secondary | Number of women diagnosed with acute MI (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | Number of women diagnosed with acute MI | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | Number of men diagnosed with acute MI (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | Number of men diagnosed with acute MI | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | The overall number of women and men diagnosed with acute MI (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | The overall number of women and men diagnosed with acute MI | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | Number of women receiving unplanned revascularization (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period.
Revascularization is defined as Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting. |
12 months after index admission | |
Secondary | Number of women receiving revascularization | Time frame starts from beginning of index admission, defined as first admission in the study period.
Revascularization is defined as Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting. |
12 months from index admission | |
Secondary | Number of men receiving unplanned revascularization (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period.
Revascularization is defined as Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting. |
12 months after index admission | |
Secondary | Number of men receiving revascularization | Time frame starts from beginning of index admission, defined as first admission in the study period.
Revascularization is defined as Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting. |
12 months from index admission | |
Secondary | The overall number of women and men receiving unplanned revascularization (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period.
Revascularization is defined as Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting. |
12 months after index admission | |
Secondary | The overall number of women and men receiving revascularization | Time frame starts from beginning of index admission, defined as first admission in the study period.
Revascularization is defined as Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting. |
12 months from index admission | |
Secondary | Number of women with all cause death (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | Number of women with all cause death | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | Number of men with over-all death (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | Number of men with over-all death | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | The overall number of women and men with over-all death (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | The overall number of women and men with over-all death | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | Number of women receiving coronary angiographies or heart CT without revascularization | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | Number of men receiving coronary angiographies or heart CT without revascularization | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | The overall number of women and men receiving coronary angiographies or heart CT without revascularization | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | Number of women receiving treatment with aspirin, dual anti-platelet therapy and/or statins | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | Number of men receiving treatment with aspirin, dual anti-platelet therapy and/or statins | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | The overall number of women and men receiving treatment with aspirin, dual anti-platelet therapy and/or statins | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | Number of women re-admitted | Readmission after index admission | 12 months after index admission | |
Secondary | Number of men re-admitted | Readmission after index admission | 12 months after index admission | |
Secondary | The overall number of women and men re-admitted | Readmission after index admission | 12 months after index admission | |
Secondary | Length of hospital stay for women | Calculated as days from date of index admission to date of discharge | 30 days | |
Secondary | Length of hospital stay for men | Calculated as days from date of index admission to date of discharge | 30 days | |
Secondary | Length of hospital stay for women and men | Calculated as days from date of index admission to date of discharge | 30 days | |
Secondary | The number of women diagnosed with myocardial injury and an event in the primary endpoint | Time frame starts from beginning of index admission, defined as first admission in the study period.
The primary endpoint is a composite of myocardial infarction, unplanned revascularisation (after index admission) or all cause mortality within 1 year of index admission. |
12 months from index admission | |
Secondary | The number of men diagnosed with myocardial injury and an event in the primary endpoint | Time frame starts from beginning of index admission, defined as first admission in the study period.
The primary endpoint is a composite of myocardial infarction, unplanned revascularisation (after index admission) or all cause mortality within 1 year of index admission. |
12 months from index admission | |
Secondary | The overall number of men diagnosed with myocardial injury and an event in the primary endpoint | Time frame starts from beginning of index admission, defined as first admission in the study period.
The primary endpoint is a composite of myocardial infarction, unplanned revascularisation (after index admission) or all cause mortality within 1 year of index admission. |
12 months from index admission | |
Secondary | The number of women diagnosed with myocardial injury | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | The number of women diagnosed with myocardial injury (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | The number of men diagnosed with myocardial injury | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | The number of men diagnosed with myocardial injury (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission | |
Secondary | The overall number of women and men diagnosed with myocardial injury. | Time frame starts from beginning of index admission, defined as first admission in the study period. | 12 months from index admission | |
Secondary | The overall number of women and men diagnosed with myocardial injury (after index admission) | Time frame starts at discharge from the hospital from the index admission, defined as first admission in the study period. | 12 months after index admission |
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