Stress CMR in Patients With Coronary Chronic Total Occlusions (CARISMA_CTO)

March 17, 2021 updated by: Massimo Lombardi, Ospedale San Donato

Stress Perfusion Cardiac Magnetic Resonance for Ischaemia and Viability Detection in Patients With Coronary Chronic Total Occlusions

A total chronic occlusion (CTO) is defined as a coronary obstruction with TIMI 0 flow lasting at least 3 months.The prevalence of CTO in patients with coronary disease is about 10-40%. Coronary collateralizations may supply sufficient perfusion to retain tissue viability, but do not protect from myocardial ischaemia. In fact, percutaneous revascularization (PCI) of CTO lesions leads to improved symptoms, functional class, quality of life, higher left ventricular ejection fraction and improved survival in several observational studies. However, due to the higher rate of procedural complications and lower success rate of PCI than in other settings, it is attempted in only 10% of all CTO lesions. Myocardial viability/ischaemia assessment should be performed before PCI to avoid potential PCI-related complications and identify patients who might benefit most from myocardial revascularization, individualizing the risk-to-benefit ratio. In this regard, patients with stable coronary artery disease who have moderate-to-severe ischaemia are at higher risk of event rates (death or MI of ~5%/year) and plausibly represent the best target for PCI.

Cardiac MRI (CMR) provide a reliable assessment of both myocardial ischaemia and viability. Using late gadolinium enhancement (LGE) sequences, myocardial segments with LGE >75% of transmurality do not show any improvement in contractility even after revascularization, representing a subset of patients in which CTO PCI may be futile. Viability assessment by CMR may be also performed with low dose dobutamine infusion; in patients with CTO and akinetic segments, contractility improvement at low dose dobutamine may predict functional recovery in the follow-up. Myocardial ischaemia may be assessed by CMR with high accuracy, identifying perfusion defects during pharmacological-induced hyperemia and/or regional wall motion abnormalities during inotrope infusion.

This study is designed to verify the hypothesis that myocardial ischaemia and viability assessed by CMR could identify patients who are more likely to benefit from PCI in terms of improvement in left ventricular remodeling, functional recovery and clinical outcome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

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

  • Italy
    • Milan
      • San Donato Milanese, Milan, Italy
        • Recruiting
        • IRCCS Policlinico San Donato
        • Contact:
          • Silvia Pica, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with angiographic evidence of CTO with planned PCI.

Description

Inclusion Criteria:

  • Angiographic diagnosis of Coronary Chronic Total Occlusion (TIMI 0 lasting more than 3 months, if known)
  • baseline stress CMR
  • signed informed consent

Exclusion Criteria:

  • CMR contraindications
  • severe CKD
  • contraindications to adenosine or dobutamine
  • unable/unwilling to sign informed consent
  • pregnancy

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Viable myocardium Group

At least ONE of the following:

  1. Late gadolinium enhancement <75%.
  2. Improvement in segmental function ≥1 grade during low dose dobutamine
Procedure: PCI
percutaneous coronary intervention attempt
Non-viable myocardium group

At least ONE of the following:

  1. Late gadolinium enhancement ≥75%.
  2. No improvement in segmental function during low dose dobutamine
Procedure: PCI
percutaneous coronary intervention attempt
Inducible ischaemia group

At least ONE of the following:

  • perfusion defect (≥ 1,5 segments) assessed during peak infusion of adenosine or dobutamine
  • new wall motion abnormalities or worsening ≥1 grade during peak infusion of dobutamine
Procedure: PCI
percutaneous coronary intervention attempt
Non-inducible ischaemia group
None of conditions qualifying for the "Inducible ischemia group"
Procedure: PCI
percutaneous coronary intervention attempt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular mechanical improvement after PCI
Time Frame: 12 +/- 3 months

At least ONE of the following:

  • Delta ejection fraction ≥ 5%
  • Segmental function improvement ≥1 grade
  • Delta end-diastolic volume ≥ 10%
  • Delta end-systolic volume ≥ 10%
12 +/- 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress ischaemia improvement after PCI
Time Frame: 12 +/- 3 months

At least ONE of the following stress CMR (adenosine or dobutamine) findings:

_<1.5 segments perfusion defect

_≥1 grade improvement in segmental wall motion abnormalities
12 +/- 3 months
Quality of life assessed by Seattle Angina Questionnaire (SAQ)
Time Frame: 12+/-3 months
Delta SAQ score
12+/-3 months
Major cardiovascular events
Time Frame: 12+/- 3 months
all-cause death, death for cardiovascular cause, life-threatening arrythmia, hospitalization for heart failure, myocardial infarction, target vessel revascularization
12+/- 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
CMR to identify re-occlusion of CTO
Time Frame: 12 +/- 3 months

Correlate angiographic CTO re-occlusion and/or critical re-stenosis with at least ONE of the following stress CMR parameters:

  • Segmental perfusion defect ≥1.5
  • New segmental contractility impairment
  • Delta ejection fraction, end-diastolic,end-systolic volume
12 +/- 3 months

Collaborators and Investigators

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

Sponsor

Ospedale San Donato

Investigators

  • Principal Investigator: Massimo Lombardi, MD, Policlinico San Donato

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)

May 10, 2017

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

May 7, 2017

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CARISMA_CTO

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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