Acute Coronary Syndrome, Stroke, Ischemic
Conditions
Keywords
stroke, troponin, acute coronary syndrome, culprit lesion
Brief summary
The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients with elevated levels of cardiac troponin.
Detailed description
Elevation of cardiac troponin can be found in about 30% of patients with acute ischemic stroke (depending on the assay used). Elevated troponin indicates increased mortality in stroke patients. There is currently little evidence regarding the ideal care of these patients. The investigators know from previous studies that approximately 25% of acute stroke patients with elevated levels of cardiac troponin have culprit lesions on coronary angiogram. The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients. To achieve this, clinical symptoms, troponin levels as well as findings on EKG, echocardiography and coronary angiography will be systematically evaluated. The PRAISE study is a multicenter study with more than 20 sites in Germany. Joint funding will be provided by DZHK (German center of cardiovascular research) und DZNE (German center of neurodegenerative diseases). Acute ischaemic stroke patients with elevated troponin are eligible for participation in the study. The primary endpoint is the diagnosis of acute coronary syndrome as established by an independent endpoint committee.
Interventions
DIAGNOSTIC_TESTCoronary angiography
In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.
Sponsors
Charite University, Berlin, Germany
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
German Center for Neurodegenerative Diseases (DZNE)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of ischemic stroke based on clinical and imaging information (CT or MRI) * diagnosis of transient ischemic attack if the initial focal neurological deficit has been examined by a neurologist and if the ABCD2-score is ≥ 4 * Elevation of high-sensitive cardiac troponins according to the rule-in/rule-out algorithm of the 2015 ESC guidelines for NSTE-ACS, i.e. highly abnormal troponin at 0 hours (\> 52ng/l if hs-cTnT, Elecsys-Assay, or \> 52ng/l, if hs-cTnI; Architect-Assay, or \> 107 ng/l, if hs-cTnI. Dimension Vista Assay) or dynamic change \> 20% of the initial value at re-test after 3 hours with at least one value above the 99th percentile of a healthy reference population * ability to give informed consent * onset of symptoms \< 72 hours prior to hospital admission
Exclusion criteria
* renal insufficiency (GFR \< 30 ml/min/m²) * contraindications for coronary angiography (e.g. manifest hyperthyroidism, allergy to contrast agent) * lesion size \> 100 ml (either on Diffusion Weighted Imaging on cMRI or on CT if CT is performed \> 24 hours after onset) or ASPECTS score \< 7 (on CT if CT is performed \< 24 hours after onset) * Premorbid degree of dependence (mRS \> 3) * pregnancy or breast-feeding * limited life expectancy \< 1 year * consent to participate in the study given \> 72 hours after hospital admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Myocardial Infarction | within seven days of admission to hospital | the diagnosis will be established by an independent endpoint committee |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | at one week and at three and twelve months after the initial event, at 12 months reported. | mortality will be recorded during the stay in hospital as well as after three and twelve months |
| Functional Outcome | at baseline, at one week and at three and twelve months after the initial event, 12 months reported | functional outcome will be evaluated using the modified Rankin scale (0-6 with greater scores indicating poorer functional outcome) |
| Cardiovascular Events | at one week and at three and twelve months after the initial event, 12 months reported | cardiovascular events include new stroke, transient ischemic attack and myocardial infarction and mortality |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stroke Patients With Elevated Troponin Patients with acute ischemic stroke (confirmed by cerebral imaging) and cardiac troponin values \> 52 ng/l or troponin values \> 14 ng/l and dynamic change \> 20% will undergo coronary angiography
Coronary angiography: In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically. | 247 |
| Total | 247 |
Baseline characteristics
| Characteristic | Stroke Patients With Elevated Troponin |
|---|---|
| Age, Continuous | 75 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 240 Participants |
| Region of Enrollment Germany | 247 participants |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 39 / 247 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 7 / 247 |
Outcome results
Primary
Presence of Myocardial Infarction
the diagnosis will be established by an independent endpoint committee
Time frame: within seven days of admission to hospital
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stroke Patients With Elevated Troponin | Presence of Myocardial Infarction | myocardial infarction | 126 Participants |
| Stroke Patients With Elevated Troponin | Presence of Myocardial Infarction | no myocardial infarction | 121 Participants |
Secondary
Cardiovascular Events
cardiovascular events include new stroke, transient ischemic attack and myocardial infarction and mortality
Time frame: at one week and at three and twelve months after the initial event, 12 months reported
Population: participants with available follow-up data on cardiovascular events
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stroke Patients With Elevated Troponin | Cardiovascular Events | 60 Participants |
Secondary
Functional Outcome
functional outcome will be evaluated using the modified Rankin scale (0-6 with greater scores indicating poorer functional outcome)
Time frame: at baseline, at one week and at three and twelve months after the initial event, 12 months reported
Population: patients with available mRS after one year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stroke Patients With Elevated Troponin | Functional Outcome | mRS 0 | 66 participants |
| Stroke Patients With Elevated Troponin | Functional Outcome | mRS 1 | 35 participants |
| Stroke Patients With Elevated Troponin | Functional Outcome | mRS 2 | 23 participants |
| Stroke Patients With Elevated Troponin | Functional Outcome | mRS 3 | 25 participants |
| Stroke Patients With Elevated Troponin | Functional Outcome | mRS 4 | 21 participants |
| Stroke Patients With Elevated Troponin | Functional Outcome | mRS 5 | 4 participants |
| Stroke Patients With Elevated Troponin | Functional Outcome | mRS 6 | 39 participants |
Secondary
Mortality
mortality will be recorded during the stay in hospital as well as after three and twelve months
Time frame: at one week and at three and twelve months after the initial event, at 12 months reported.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stroke Patients With Elevated Troponin | Mortality | number of patients dead after one year | 39 Participants |
| Stroke Patients With Elevated Troponin | Mortality | number of patients alive after one year | 208 Participants |