Stress CMR in Patients With Coronary Chronic Total Occlusions

NCT03152825 | Unknown

• 1 other identifier: CARISMA_CTO
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Chronic Total Occlusions

Keywords

myocardial ischaemia; myocardial viability; coronary chronic total occlusions; cardiac magnetic resonance; stress CMR

Outcome Measures

Primary Outcomes (1)

• Left ventricular mechanical improvement after PCI

  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 Outcomes (3)

• Stress ischaemia improvement after PCI

  12 +/- 3 months

• Quality of life assessed by Seattle Angina Questionnaire (SAQ)

  12+/-3 months

• Major cardiovascular events

  12+/- 3 months

Other Outcomes (1)

• CMR to identify re-occlusion of CTO

  12 +/- 3 months

Study Arms (4)

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

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

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

Non-inducible ischaemia group

None of conditions qualifying for the "Inducible ischemia group"

Procedure: PCI

Interventions

PCI PROCEDURE

percutaneous coronary intervention attempt

Inducible ischaemia group; Non-inducible ischaemia group; Non-viable myocardium group; Viable myocardium Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with angiographic evidence of CTO with planned PCI.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale San Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, Italy

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Massimo Lombardi, MD

  Policlinico San Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Lombardi, MD

CONTACT

+390252774376; massimo.lombardi@grupposandonato.it

Silvia Pica, MD

CONTACT

+390252774376; silvia.pica@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Multimodality Cardiac Imaging Unit

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 15, 2017
• Study Start: May 10, 2017
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

IT (1)