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Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia (EVAOLD)

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ClinicalTrials.gov Identifier: NCT03289728
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

The WHO predicts that cardiovascular morbi-mortality will increase by 120-137% within 20 years due to the aging population. Myocardial infarction without ST segment elevation (NSTEMI) is the most common form of infarction. However, its treatment among elderly patients remains a challenging question.

Indeed, the risk benefit balance of revascularization remains unclear, and complications related to revascularization are more frequent in the elderly, including MI, heart failure, stroke, renal failure and bleeding according to National Cardiovascular Network data.The last randomized controlled trial "After Eighty Study", showed a reduction of major cardio-cerebrovascular events (MACCEs) in NSTEMI patients with an invasive strategy (systematic coronary angiography - CA) compared to a conservative strategy (medical treatment alone). Nevertheless, this study presented several limitations of which a major one was the lack of a definition of frailty at inclusion. Moreover, the "After Eighty Study" has shown that percutaneous revascularization in the invasive arm was only performed for 1 in 2 patients showing an inadequacy in the strategy for selecting candidates for revascularization.

Consequently, despite European Society of Cardiology (ESC) guidelines, the management of NSTEMI in elderly patients is not yet evidence based, and current recommendations do not provide any clear clinical decision rule indicating one strategy over another.

For fragile patients, an alternative strategy consists of selecting candidates for a guided CA according to the extent of myocardial ischemia, identified by non-invasive imaging. Single-photon emission computed tomography or dobutamine stress echocardiograms are currently the reference methods with well-defined interpretation of ischemia. According to our experience, this strategy avoids CA for one third of patients and improves the rate of revascularization.

The aim of our study is to compare 1-year morbidity and mortality in NSTEMI patients over 80 years, assigned to guided versus systematic-CA. Our hypothesis is that the guided strategy will not be inferior on MACE rates at 1 year, and will be cost-effective by reducing iatrogenic complications.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE) Procedure: Cornorary angioplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial.
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dobutamine

Arm Intervention/treatment
Experimental: Strategy guided by ischemia imaging

Non-invasive imaging (SPECT or DSE) will be performed. High-risk Patients judged to high risk by imaging (according to ESC guidelines (5)) will undergo coronary angiography aimed at myocardial revascularization and have optimal medical treatment, according to ESC guidelines.

- Low or intermediate risk patients will receive optimal medical treatment.

Other: Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE)

Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE), performed using standard protocol.

Patients with ≥ moderate ischemia observed by SPECT (≥ 10% of the myocardium or transient ischaemic dilatation or reduced post-stress ejection fraction (EF)) or abnormal movements of the myocardial walls observed during a stress echocardiogram (≥ 3/17 segments) will benefit from coronary angiography. Depending on the results of coronary angiography and on the coronary anatomy and other clinical and para-clinical considerations (territory of myocardial ischemia) revascularisation will be performed (REVASC). Patients with < moderate ischemia will receive medical treatment only (MT).


Active Comparator: Systematic coronary angioplasty
Patients will routinely undergo invasive coronary angiography aimed at myocardial revascularization.
Procedure: Cornorary angioplasty
Participants randomized to the SCA group, will benefit from a coronary angiography within 24 to 72 hours after the diagnosis of NSTEMI; without any preliminary ischemia imaging.




Primary Outcome Measures :
  1. Rate of MACCE [ Time Frame: 12 months ]
    Rate of MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)


Secondary Outcome Measures :
  1. Rate of MACCEs and each component of the MACCEs criteria during index hospitalization [ Time Frame: 1, 6 and 12 months ]
    MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)

  2. Incremental cost-effectiveness ratio (ICER) expressed as the extra cost for a QALY (quality adjusted life year) gained by the strategy guided by ischemia imaging compared to the systemic coronary angioplasty strategy [ Time Frame: 12 months ]
  3. The annual financial impact of implementing the strategy guided by ischemia imaging will be calculated from the French Health Insurance System perspective over three years [ Time Frame: 12 months ]
  4. Quality of life using standardized scale : EQ5D-5L [ Time Frame: 1, 6 and 12 months ]
  5. Frailty assessment [ Time Frame: 1 week ]
    Multiple assessment are necessary to evaluate patient frailty: ADL, IADL, CAM, MNA, Charlson score, SEGA, MMSE, Time up and go test, mini GDS, history of fall

  6. Dependency (ADL) [ Time Frame: 1, 6, 12 months ]
  7. Autonomy (IADL) [ Time Frame: 1, 6, 12 months ]
  8. Incidence of bledding events as defined by the Bleeding Research Consortium (BARC) score [ Time Frame: 1. 6, 12 months ]
  9. Rate of MACCE according to sub-group analysis [ Time Frame: 1. 6, 12 months ]
    Sub group : age, gender, diabetes, renal failure and frailty

  10. Create prognostic model with multivariate survival analysis : [ Time Frame: 1. 6, 12 months ]
    Risk Algorithm, setting up a score to choose an invasive strategy or not based on analysis of different score (for example geriatric score)



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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 80 years or older
  • Hospitalized for NSTEMI with or without ST-segment depression on electrocardiogram (ECG), and with raised blood concentration of troponin T or I. Raised troponin was defined as a value exceeding the 99th percentile of a normal population at the local laboratory at each participating site. A local cardiologist assessed patient eligibility and clinical condition compatible with a doubt for systematic coronary angiography due to a frailty.
  • Written informed consent by the patient or the next of kin in case of incapacity.

Non-inclusion criteria:

  • Recurrent or ongoing chest pain refractory to medical treatment
  • Haemodynamic instability or cardiogenic shock
  • Life-threatening arrhythmias or cardiac arrest
  • Contra-indication to CA: Renal failure (creatinine clearance <15 mL/min by Modification of the Diet in Renal Disease (MDRD)), continuing bleeding problems
  • Mechanical complications of MI
  • Severe aortic stenosis
  • Medical history of severe dementia (documented for more than 3 months)
  • Patient under administrative or judicial control
  • Patient who are protected under the act
  • No health care insurance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289728


Contacts
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Contact: Gilles Barone-Rochette, MD, PhD +33476765172 gbarone@chu-grenoble.fr
Contact: Clémence CHARLON ccharlon@chu-grenoble.fr

Locations
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France
Clinique Mutualiste Recruiting
Grenoble, France
Principal Investigator: BENJAMIN FAURIE, MD         
University Hospital Grenoble Recruiting
Grenoble, France
Contact: GILLES BARONE ROCHETTE, MD PHD         
Contact: CLEMENCE CHARLON       CCHARLON@CHU-GRENOBLE.FR   
Principal Investigator: GILLES BARONE ROCHETTE, MD PHD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Gilles Barone-Rochette, MD, PhD University Hospital, Grenoble
Publications of Results:
Task Force Members, Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabaté M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines, Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers, Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Rydén L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. Erratum in: Eur Heart J. 2014 Sep 1;35(33):2260-1.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03289728    
Other Study ID Numbers: 38RC17.012
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
elderly patients
myocardial infarction
myocardial revascularization strategy
ischemia imaging
coronary artery disease
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents