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

May 25, 2023 updated by: University Hospital, Grenoble

Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1756

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France
        • Recruiting
        • University Hospital Grenoble
        • Contact:
        • Contact:
          • GILLES BARONE ROCHETTE, MD PHD
        • Principal Investigator:
          • GILLES BARONE ROCHETTE, MD PHD
      • Grenoble, France
        • Recruiting
        • Clinique Mutualiste
        • Principal Investigator:
          • BENJAMIN FAURIE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of MACCE
Time Frame: 12 months
Rate of MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1, 6 and 12 months
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
12 months
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
12 months
Quality of life using standardized scale : EQ5D-5L
Time Frame: 1, 6 and 12 months
1, 6 and 12 months
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
1 week
Dependency (ADL)
Time Frame: 1, 6, 12 months
1, 6, 12 months
Autonomy (IADL)
Time Frame: 1, 6, 12 months
1, 6, 12 months
Rate of MACCE according to sub-group analysis
Time Frame: 1. 6, 12 months
Sub group : age, gender, diabetes, renal failure and frailty
1. 6, 12 months
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)
1. 6, 12 months
Incidence of bledding events as defined by the Bleeding Research Consortium (BARC) score ≥ 3
Time Frame: 1. 6, 12 months
1. 6, 12 months
Rate of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, resuscitated cardiac arrest and ischemia-driven coronary revascularization procedure
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Gilles Barone-Rochette, MD, PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2018

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (Actual)

September 21, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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