Clinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip Positioning

NCT03145376 | Unknown

• 1 other identifier: TaMi01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Since October of 2014, the Policlinico Umberto I Hospital has an "Heart Team", a group of selected specialists with the task of assessing and identifying eligible patients for valvular aortic transcatheter implantation (TAVI) or a placement of a MitraClip . The specialists taking part to Heart Team are: a cardiologist, a heart surgeon, a vascular surgeon, an anesthesiologist and a geriatrician. The Geriatrician is called to make a careful multidimensional assessment of the elderly patients who have been suggested for the interventions mentioned above. His role is to assess the degree of co-morbidity and polypathology, autonomy in the common activities of daily living, nutritional status, cognitive status and quality of life. Following this evaluation, together with the other components of Heart Team, it is expressed a collective judgment on the patient's eligibility to these interventions. So, the aim of the present study is to identify changes in the degree of cognitive decline, of autonomy in carrying out activities of daily living, quality of life, nutritional status, pre- and postoperatively (6 months after the procedure) polypathology degree in elderly patients to be undergone or undergoing TAVI or positioning MitraClip because suffering from aortic valvular stenosis or severe mitral insufficiency. The patients undergo to a battery of tests, to a 5 minutes electrocardiographic record to evaluate the Heart Rate Variability (HRV) and to a complete echocardiographic evaluation.

Conditions

Mitral Valve Insufficiency; Aortic Stenosis Senile

Keywords

TAVI; MitraClip; geriatric assessment; heart rate variability; elderly

Outcome Measures

Primary Outcomes (1)

• Changes in cognitive impairment evaluation using minimental state examination (MMSE)

  evaluation of the pre and post-operative cognitive impairment using the same test (mini mental state examination, MMSE: tot 28-30 points no cognitive impairment, 24-27 borderline, 19-23 mild cognitive impairment, 14-18 moderate cognitive impairment, \<14 severe cognitive impairment)

  Baseline evaluation and a new one after 6 months to evaluate possible changes

Secondary Outcomes (6)

• Quality of Life

  Baseline evaluation and a new one after 6 months

• polypathology status evaluation with CIRS scale

  Baseline evaluation and a new one after 6 months

• ADL: Activities of Daily Living

  Baseline evaluation and a new one after 6 months

• IADL:InstrumentalActivities of Daily Living

  Baseline evaluation and a new one after 6 months

• MNA:Mini Nutritional Assessment

  Baseline evaluation and a new one after 6 months

Study Arms (1)

patients before and after TAVI/MitraClip

geriatric assessment of patients before and after TAVI/Mitraclip

Diagnostic Test: geriatric assessment

Interventions

geriatric assessment DIAGNOSTIC_TEST

1. Clinical evaluation and geriatric assessment with: 1. CIRS: CIRS (Cumulative Illness Rating Scale) 2. ADL (Activities of Daily Living); 3. IADL (InstrumentalActivities of Daily Living); 4. Mini Nutritional Assessment; 5. Evaluation of quality of life (Short Form 36, SF-36). 2. Making a traditional 12-lead ECG. 3. A single lead electrocardiographic registration (DI, D II and D III) of 5 minutes baseline and 5 minutes with controlled breathing (15 breaths / min), using the Spectralink 2011 program, which allows us to identify and calculate the variables object of study; 4. transthoracic echocardiogram.

Also known as: ECG, Heart Rate Variability, Echocardiogram

patients before and after TAVI/MitraClip

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

elderly patients with severe aortic stenosis eligible for TAVI or affected by mitral valve severe insufficiency treatable by MitraClip positioning.

You may qualify if:

• Age higher than or equal to 65 aa;
• the capacity to perform geriatric assessment tests;
• sinus rhythm at the time of evaluation (for the evaluation of HRV only);
• to sign appropriate informed consent.

You may not qualify if:

• altered cognitive abilities such as to impair the evaluation;
• hemodynamically unstable patient;
• Inability or unwillingness to sign informed consent.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (2)

Gianfranco Piccirillo

Rome, 00186, Italy

NOT YET RECRUITING

Policlinico Umberto I

Rome, 00186, Italy

RECRUITING

Related Publications (1)

• Piccirillo G, Moscucci F, Mastropietri F, Di Iorio C, Mariani MV, Fabietti M, Stricchiola GM, Parrotta I, Sardella G, Mancone M, Magri D. Possible predictive role of electrical risk score on transcatheter aortic valve replacement outcomes in older patients: preliminary data. Clin Interv Aging. 2018 Sep 11;13:1657-1667. doi: 10.2147/CIA.S170226. eCollection 2018.

  PMID: 30237702 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Electrocardiography; Echocardiography

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography

Study Officials

• Gianfranco Piccirillo, MD, PhD

  Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianfranco Piccirillo, MD, PhD

CONTACT

+393356759046; gianfranco.piccirillo@uniroma1.it

Federica Moscucci, MD

CONTACT

+393403304642; federica.moscucci@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: May 9, 2017
• Study Start: June 1, 2017
• Primary Completion: May 30, 2020
• Study Completion: October 30, 2020
• Last Updated: October 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)