Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02386124 |
| Other study ID # |
140994 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2014 |
| Est. completion date |
April 28, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University Hospital of Ferrara |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50
years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%,
respectively, due to more effective therapies and lower mortality of many diseases. Yet,
chronic diseases are nowadays more important, and often coexist as comorbidity or
multimorbidity, depending on whether an index condition has been considered. These conditions
increase the risk of death and reduce functional autonomy in the elderly and, therefore,
should be carefully considered within comprehensive geriatric assessment. The epidemiology of
cardiovascular disease, as demonstrated among others by the Oxford Vascular Study, shows a
clear trend in age-dependent, as the number of events and their incidence increases with age,
and about half are concentrates over 75 years.
In addition, some observational studies in elderly patients have suggested an association
between frailty and cardiovascular disease: fragility and cardiovascular disease share a
common biological pathway, and cardiovascular diseases may accelerate the onset of frailty.
The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease,
according to the rating scale used and the population studied. Frail patients with
cardiovascular disease, in particular those undergoing invasive procedures or suffering from
coronary artery disease and aortic valve disease, have a much higher adverse events and
complications, suggesting the need for a more accurate functional stratification and a more
careful evaluation of the risk/benefit ratio of some invasive procedures.
Among the numerous tests proposed in the literature for the functional evaluation and
objective measures of physical capability in elderly patient, the Short Physical Performance
Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those
characterized by an improved prognostic ability and an easy administration.
The present study is performed to assess if SPPB and handgrip are helpful to better stratify
the prognosis (all-causes death and hospital admission for all causes) in elderly patients
admitted to hospital for cardiac causes.
Description:
This is a prospective observational study. This a multicenter study involving 4 Italian
Cardiology Units (Ferrara, Cento, Forlì, Ravenna).
The study is expected to enroll at least 400 consecutive patients with ≥70 years, which are
admitted to our cardiovascular departement for:
- GROUP A: acute coronary syndrome,
- GROUP B: bradycardia or tachyarrhythmias requiring device implantation (pace-maker,
implantable cardioverter defibrillator, cardiac resynchronization therapy)
- GROUP C: acute heart failure.
- GROUP D: symptomatic severe aortic stenosis receiving aortic valve replacement or aortic
balloon valvuloplasty or transcatheter aortic valve implantation.
The main group of the study is the group A. The Authors will enroll at least 300 patients of
the group A. The main finding of the study will be for ACS patients. The results of group A
will be reported by Authors in a separate and principal paper.
To generate hypothesis for future studies, the Authors will enroll also other groups of
patients admitted to hospital for cardiac cause (group B, C and D). These patients will be
object of separate publications.
In all patients, the following functional assessments will be performed before the hospital
discharge:
- handgrip test (see definition below).
- Short Portable Mental Status Questionnaire (SPMSQ, see definition below).
- Short Physical Performance Battery (SPPB, see definition below).
- Multidimensional Prognostic Index (MPI, see definition below).
The aim of the study is to evaluate if SPPB value is able to stratify prognosis in elderly
patients admitted to hospital for cardiac causes.
DEFINITION OF ACUTE CORONARY SYNDROME.
As suggested by current guidelines, we define a patient suffering from ACS if he meets the
following criteria (the first mandatory which must add up to at least one criterion 2 or 3):
1. chest pain suggestive of cardiac origin lasting at least 20 minutes.
2. ECG changes compatible with signs of myocardial ischemia (ST over at least one mm in at
least two contiguous leads or new onset left bundle branch block not known before or
ST-segment depression of at least one mm in at least two contiguous leads or negative/
flattening of T wave)
3. detection of rise of cardiac biomarker values with at least one value above the 99th
percentile of the upper reference in two consecutive blood samples
DEFINITION OF ACUTE MYOCARDIAL INFARCTION (ESC GUIDELINES 2012)
The term acute myocardial infarction should be used in case of evidence of myocardial
necrosis in a clinical picture compatible with acute myocardial ischemia. And in particular
it must verify detection of movement enzyme preferentially typical of troponin above the 99th
percentile than the limit of the standard and in the presence of at least one of the
following conditions:
- Symptoms of ischemia,
- Changes in de novo ST-segment and T-wave, new-onset left bundle branch block,
development of pathological Q waves on the ECG.
- Evidence of loss of viable myocardium imaging or detection of new wall motion defects,
- Identification of an intracoronary thrombus on coronary angiography.
DEFINITION OF HEART FAILURE (ESC GUIDELINES 2012) It defines heart failure or an abnormality
of the structure of the cardiac function that involves an insufficient ability of the heart
to provide for the oxygen requirements in relation to the metabolic demands of the tissues,
despite normal or increased filling pressures. Heart failure is a syndrome that is
characterized by the presence of typical symptoms (dyspnea, peripheral edema and fatigue) and
signs resulting from an abnormality of cardiac structure and function.
DEFINITION AND METHODS OF ASSESSMENT TEST DELL'HANDGRIP (HGT). The handgrip test measures the
force of contraction of the flexor muscles of the fingers through the use of a dynamometer.
From literature it is known as such index correlates with the eventual malnutrition of the
subject, with its capacity of recovery and functional recovery post-surgery, as well as to be
in relation with age. The measurement will be made at the time of admission, namely within 24
hours of admission in acute coronary care in the event that the patient is admitted with a
diagnosis of acute myocardial infarction with ST-segment elevation or before being subjected
to coronary angiography in case aortic valve disease or acute coronary syndrome without
ST-segment elevation, under the supervision and assistance of medical staff. In each patient,
three measurements will be carried out. Will be taken into consideration for the study the
highest value. The measurement will be performed as indicated by current guidelines, with the
patient seated, with the dominant hand and the elbow flexed 90°. They are well known
limitations of the method and its variability. At the same time this method was chosen
because it is not laborious, virtually cost-free, well-administered in all patients admitted
for ACS or aortic valve disease and therefore readily identifiable as a method of coarse
screening in elderly patients without known diagnosis of "frail elderly" but at risk to be.
All medical personnel involved in the study performed a specific course to learn the proper
management and execution of screening with handgrip tes and has personal experience in its
proper execution.
SHORT PHYSICAL PERFORMANCE BATTERY (SPPB). The scale SPPB is a short battery of tests created
to evaluate the functionality of the lower limbs. This battery is made up of 3 different
sections designed to assess a balance with 3 tests: the maintenance of the position with the
feet together for 10 seconds then the semi-tandem and finally tandem again for 10 seconds.
The score of this section varies from a minimum of 0 if the patient is unable to maintain
position with your feet together for at least 10 seconds to a maximum of 4 if he can
accomplish all three tests. The second section of the test is intended to evaluate the
progress of 4 linear meters and depending on the time of the performance section of the score
ranges from 0 if unable, at one point if the performance has a longer duration of 8.7
seconds, for a up to 4 if he can accomplish the task in less than 4.80 sec. The third section
investigates the ability of the battery to run for 5 consecutive times, getting up from a
chair without using the arms in this regard that must be crossed in front of chest. Also in
this case, the score ranges from 0 incapable or if the performance has a duration greater
than 60 seconds, to a maximum of 4 if such performance is carried out in less than 11.20
seconds. The scores range from 0 (worst performance) to 12 (best performance).
A score between 5 and 9 shows seniors still independent, but with reduced physical
performance, which can therefore be regarded as fragile and high risk, deserving of special
attention and specific interventions, acts to reduce the risk of adverse consequences. Data
in the literature confirm that the SPPB correlates with the risk of developing disability in
BADL and mobility, in proportion to the decrease of the SPPB score, regardless of age, sex
and presence of certain chronic diseases. The SPPB score then emerges as a powerful predictor
of disability and mortality in the elderly population. The battery SPPB proved to be a valid
predictor of prognosis in heart patients: in elderly hospitalized for acute exacerbation of
chronic heart failure, the SPPB score at discharge was able to predict the long-term
mortality. This assessment thus appears to be safe and feasible in hospitalized patients:
test will be performed in patients with hemodynamic stabilization prior to discharge.
MULTIDIMENSIONAL PROGNOSITC INDEX (MPI)
The Multidimensional Prognostic Index (MPI) is a prognostic tool based on a standard
Comprehensive Geriatric Assessment (CGA) that predicts short- and long-term mortality in
elderly subjects. The MPI includes 63 items distributed in 8 domains of CGA as follows:
1. Activities of Daily Living (ADL): 6 items
2. Instrumental Activities of Daily Living (IADL): 8 items
3. Short Portable Mental Status Questionnaire (SPMSQ): 10 items
4. Mini Nutritional Assessement (MNA): 18 items
5. Exton-Smith Scale (ESS): 5 items
6. Cumulative Index Rating Scale - Comorbidity Index (CIRS-CI): 14 items
7. Number of drugs used: 1 item
8. Co-habitation status: 1 item On the basis of MPI values, it is possible to calculate the
short- and long-term mortality risk of the older subjects and to define the severity
grade of mortality risk: low, moderate and severe. Several studies showed that the
prognostic accuracy of the aggregated MPI was significantly greater than the prognostic
accuracy of its individual components considered singularly. Thus the multidimensional
approach can be successfully used in elderly patients for both clinical and
administrative purposes.
