Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04488536 |
| Other study ID # |
2020-01708 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 29, 2020 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Linkoeping University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Background Patients less than 80 years of age, who suffer a myocardial infarction (MI) are
usually (>90%) offered an early invasive strategy including coronary angiography possibly
followed by intervention, preferably percutaneous coronary intervention (PCI). Among non
ST-elevation myocardial infarction (NSTEMI) patients, 80 years of age or over, only
approximately 40% receive an invasive approach in Sweden, since the majority are handled in a
conservative way, i.e. with medical treatment only. Furthermore, as with pharmacological
treatment, there is a large variation between Swedish counties regarding the choice of
strategy for the treatment of elderly (80+) patients with NSTEMI with an even larger
variation between acute hospitals ranging from 20% to 90 %.
The Swedish national guidelines for heart disease have emphasized that the patient's
biological age, i.e. the patient's biological status and expected length of life, is crucial
for decision-making. The Clinical Frailty Scale (CFS) is a global clinical measure of
biological age, mixing co-morbidity, disability and cognitive impairment. The investigators
have previously reported the potential importance of frailty for short-term (1 month) and
medium-term outcome (1 year) in a NSTEMI population. However, published data on the role of
frailty´s prognostic value, its capacity to predict adverse effects including complications,
and the potential to guide clinical decision-making for elderly patients with myocardial
infarction are scarce. Similarly, there is a lack of knowledge of how different patterns of
comorbidity burden might influence rational decision-making.
Aims To explore the association between frailty and treatment patterns in cardiac care To
study the association between outcomes and degree of frailty, with and without comprehensive
adjustment for differences in baseline characteristics.
To study how treatment benefits for patients admitted to coronary care units differ in
patients depending on comorbidities and frailty.
Hypothesis The investigators hypothesize that frailty is independently associated with worse
outcomes, including mortality, readmissions and complications.
Methods and material An observational, register based, multicentre study. Inclusion criteria:
Patients consecutively included in the Swedish Web-System for Enhancement and Development of
Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies
(SWEDEHEART) registry. Exclusion criteria: None.
SWEDEHEART is a national quality registry collecting information on all patients hospitalized
with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with
data. Briefly, information is collected prospectively about individual patients' medical
history, treatment before admission, management during hospital stay, treatment at discharge,
and diagnoses. Approximately 20.000 patients diagnosed with MI are included in this register
per year. From January 1st 2020 frailty (CFS) is a mandatory variable in the registry.
However, as a pilot project to ensure feasibility, five hospitals began to register frailty
November 1st, 2017. For the investigators initial analyses data will be used from the pilot
study to assess the association between CFS level and outcomes. The data extraction will be
done by one of the monitors of the SWEDEHEART registry. After about two years the
investigators will extract data prospectively entered into the registry.
The frailty instrument The crucial study instrument CFS is a 9-point scale. It has good
predictive validity and prognostic power, is relying on clinical judgment, and is relatively
easily used in clinical practice. Since the scale includes several degrees it can be
considered to be particularly appropriate for risk stratification, and accordingly it has
been used for this purpose. The investigators have got the instrument owner´s permission to
use this scale.
The case record form (CRF) focus on demographic and clinical patient characteristics
registered in the SWEDEHEART, particularly those which are supposed to be potential
confounders when testing the hypothesis: chronological age, gender, cardiovascular risk,
diabetes, heart failure, renal insufficiency, other co-morbidities, including the Charlson
Comorbidity Index (CCI), previous MI, medications, ejection fraction, and the classification
of MI. Cardiovascular risk will be assessed according to the Global Registry of Acute
Coronary Events (GRACE) risk score (GRS). Results from echocardiography, ECGs, laboratory
testing and registration of anthropometric data will be included according to routine
practice within the frame of SWEDEHEART.
Follow-up of cohorts of invasively or conservatively treated patients with different stages
of frailty will be done one, three, six, 12, 24 and 36 months after the inclusion point
respectively.
Description:
Background In Western countries the numbers of elderly patients are increasing. Although many
elderly individuals are healthy, the number of individuals with complex needs for health care
is large and growing. Patients less than 80 years of age, who suffer a myocardial infarction
are usually offered an early invasive strategy including coronary angiography possibly
followed by intervention, preferably percutaneous coronary intervention (PCI). Among non
ST-elevation myocardial infarction (NSTEMI) patients, 80 years of age or over, only
approximately 40% receive an invasive approach in Sweden, since the majority are handled in a
conservative way, i.e. with medical treatment only. Furthermore, as with pharmacological
treatment, there is a large variation between Swedish counties regarding the choice of
strategy for the treatment of elderly (80+) patients with NSTEMI with an even larger
variation between acute hospitals ranging from 20% to 90 %.
The Swedish national guidelines for heart disease have emphasized that the patient's
biological age, i.e. the patient's biological status and expected length of life, is crucial
for decision-making, though there is limited guidance regarding how the biological age should
be estimated.The term frailty denotes a multi-dimensional syndrome characterized by increased
vulnerability and decreased physiologic reserves, which can be seen as a marker of biological
age.
The Canadian Study of Health and Ageing (CSHA) Clinical Frailty Scale (CFS) is a global
clinical measure of biological age, mixing co-morbidity, disability and cognitive impairment.
The CFS might be the most commonly used frailty instrument in an acute care context. The
investigators have previously reported the potential importance of frailty for short-term (1
month) and medium-term outcome (1 year) in a NSTEMI population. However, published data on
the role of frailty´s prognostic value, its capacity to predict adverse effects including
complications, and the potential to guide clinical decision-making for elderly patients with
myocardial infarction are scarce, particularly regarding longer-term outcomes.Similarly,
there is a lack of knowledge of how different patterns of comorbidity burden, e.g. measured
by a well-established index like the Charlson Comorbidity Index (CCI) might influence
rational decision-making. Particularly this might be true regarding the combination of
frailty and comorbidity.
The large variation in the management of these patients shows that there is need for further
studies within this area in order to determine which treatment one should chose, whether it
be invasive or conservative, in different groups.
Aims To explore the association between frailty and treatment patterns in cardiac care To
study the association between outcomes and degree of frailty, with and without comprehensive
adjustment for differences in baseline characteristics.
To study how treatment benefits for patients admitted to coronary care units differ in
patients depending on comorbidities and frailty.
Hypothesis The investigators hypothesize that frailty is independently associated with worse
outcomes, including mortality, readmissions and complications.
The investigators also hypothesize that frailty influences the benefit-risk ratio for
pharmacological therapies and invasive treatments.
Methods and material An observational, register based, multicentre study. Inclusion criteria:
Patients consecutively included in the SWEDEHEART registry. Exclusion criteria: None.
SWEDEHEART is a national quality registry collecting information on all patients hospitalized
with MI or suspected MI. All 72 Swedish hospitals with acute coronary care contribute with
data. Briefly, information is collected prospectively about individual patients' medical
history, treatment before admission, management during hospital stay, treatment at discharge,
and diagnoses. Approximately 20.000 patients diagnosed with MI are included in this register
per year. From January 1st 2020 frailty (CFS) is a mandatory variable in the registry.
However, as a pilot project to ensure feasibility, five hospitals began to register frailty
November 1st, 2017. These include three university hospitals: the Huddinge-Karolinska
Hospital, the Linköping University Hospital and the Sahlgrenska Hospital, and two large
county hospitals: The NAL-Uddevalla (NU) Hospital and Gavle Hospital. For the investigators
initial analyses data will be used from the pilot study to assess the association between CFS
level and outcomes. The data extraction will be done by one of the monitors of the SWEDEHEART
registry. After about two years the investigators will extract data prospectively entered
into the registry. By use of the Swedish unique personal identification numbers (PIN) data
from the SWEDEHAERT will be merged with data from the National cause of death registry in
order to obtain information on mortality and cause of death, with the National patient
registry, a comprehensive national register of the consumption of inpatient hospital care
maintained by the Swedish National Board of Health and Welfare, to obtain information on
comorbidity and outcomes, with the Swedish prescribed drugs registry to obtain information on
collected drugs and from Statistics Sweden information on socio-economic factors and country
of birth. After data extraction, merging PINs will be removed and all statistical analyses
will be performed on de-identified data.
The frailty instrument The crucial study instrument CFS is a 9-point scale, derived from the
deficit of accumulation model of frailty, and it has been validated against the Frailty
Index. It has good predictive validity and prognostic power, is relying on clinical judgment,
and is relatively easily used in clinical practice, see the attached document Clinical
Frailty Scale. Since the scale includes several degrees it can be considered to be
particularly appropriate for risk stratification, and accordingly it has been used for this
purpose. The investigators have got the instrument owner´s permission to use this scale.
The evaluation of the patient's degree of frailty will be based on bedside judgment
undertaken preferably by registered nurses regarding frailty and other clinical information
including the records in the patient file. The inter-rater reliability among a sample of
frailty-assessing nurses will be pragmatically assessed before the study start, see
Statistics. During the study there will be several support functions in order to enhance the
validity and reliability of the judgments: a manual and an instruction film on the frailty
assessment via CFS has been developed by a focus group including cardiological and geriatric
expertise; there will be instructions on how to assess frailty on the homepage of SWEDEHEART;
and five trained SWEDEHEART nurses will function as monitors and support for the local
assessing nurses, as will the mentioned expert group.
The CRF focus on demographic and clinical patient characteristics registered in the
SWEDEHEART, particularly those which are supposed to be potential confounders when testing
the hypothesis: chronological age, gender, cardiovascular risk, diabetes, heart failure,
renal insufficiency, other co-morbidities, including the Charlson Comorbidity Index (CCI),
previous MI, medications, ejection fraction, and the classification of MI. Cardiovascular
risk will be assessed according to the Global Registry of Acute Coronary Events (GRACE) risk
score (GRS).
Results from echocardiography, ECGs, laboratory testing and registration of anthropometric
data will be included according to routine practice within the frame of SWEDEHEART.
Follow-up of cohorts of invasively or conservatively treated patients with different stages
of frailty will be done one, three, six, 12, 24 and 36 months after the inclusion point
respectively.
