Coronary Revascularization Based on CMR Viability Study Vs Direct Revascularization in Ischemic Cardiomyopathy Patients

NCT05194865 | Unknown

• 1 other identifier: CMR Vs PCI revascularization
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aiming to demonstrate the baseline characteristics and outcomes of patients undergoing revascularization by PCI vs those kept only on medical treatment, based on CMR viability assessment.

Conditions

Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Detection of death, myocardial infarction , arrhythmia and hospitalization for HF

  Detection of death, myocardial infarction (not related to index procedure) and hospitalization for heart failure or arrhythmia at 6-12 months after revascularization or medical treatment based on CMR viability testing.

  6-12 months after revascularization or medical treatment based on CMR viability testing.

Secondary Outcomes (3)

• - Quality of life assessment using Kansas Qol questionnaire.

  6-12 months after revascularization or medical treatment based on CMR viability testing.

• - Improvement of echocardiography measured LVEF at 6-12 months after revascularization.

  6-12 months after revascularization or medical treatment based on CMR viability testing.

• - Detection of the effect of delayed revascularization after the CMR viability study on the outcome.

  6-12 months after revascularization or medical treatment based on CMR viability testing.

Study Arms (2)

CMR viability study group

Diagnostic Test: CMR Basic CMR data including LV and RV volumes, SWMA reported, EF and wall thinning will be collected. * SWMA from SSFP sequences will be reported and numbered according to the usual (1 normal, 2 hypokinetic, 3 akinetic, 4 dyskinetic, 5 aneurysmal). * Data of viability assessed with LGE imaging with scar measurement using standard deviation method with SD of 4-5 will be used. * AHA 17 segment model will be used as a reference for LV segmentation. * Viability scoring will be calculated for each segment based on the transmurality index, in a semiautomated method, with no scar given 0, 1-25% subendocardial scar given score 1, 25-50% given 2, 50-75% given 3, \>75% as 4. * Wall thinning will be given 0 or 1 score for each segment, with 1 given for \<6 mm thickness.

Device: cardiac MRI

direct revascularization group

Direct Coronary revascularization

Procedure: Percutaneous coronary intervention

Interventions

cardiac MRI DEVICE

assessment of the viability using CMR

Also known as: CMR

CMR viability study group

Percutaneous coronary intervention PROCEDURE

direct revascularization using PCI

Also known as: PCI

direct revascularization group

Eligibility Criteria

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

Study Population

Ischemic cardiomyopathy patients

You may qualify if:

• Patients \>18 years of age, with LVEF\<40%.
• Patients presenting for viability assessment to Assiut university Heart Hospital, starting from October 2020 till September 2021, will be retrospectively recruited.
• Patients with a coronary angiography that is amenable for revascularization. The decision and type of revascularization will be determined by the treating physicians.

You may not qualify if:

• Classic CMR and gadolinium-based dye contraindications including non-MRI compatible implants/foreign bodies (e.g. non-MRI compatible pacemaker, large pieces of shrapnel) and patients with eGFR\<30 ml/min/1.73 m2.
• Patients with non-ischemic cardiomyopathy confirmed by both CMR and coronary angiography.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Cerqueira MD, Weissman NJ, Dilsizian V, Jacobs AK, Kaul S, Laskey WK, Pennell DJ, Rumberger JA, Ryan T, Verani MS; American Heart Association Writing Group on Myocardial Segmentation and Registration for Cardiac Imaging. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart. A statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Circulation. 2002 Jan 29;105(4):539-42. doi: 10.1161/hc0402.102975. No abstract available.

  PMID: 11815441 BACKGROUND

• Garcia MJ, Kwong RY, Scherrer-Crosbie M, Taub CC, Blankstein R, Lima J, Bonow RO, Eshtehardi P, Bois JP; American Heart Association Council on Cardiovascular Radiology and Intervention and Council on Clinical Cardiology. State of the Art: Imaging for Myocardial Viability: A Scientific Statement From the American Heart Association. Circ Cardiovasc Imaging. 2020 Jul;13(7):e000053. doi: 10.1161/HCI.0000000000000053. Epub 2020 Jul 13.

  PMID: 32833510 BACKGROUND

• Bax JJ, Delgado V. Myocardial viability as integral part of the diagnostic and therapeutic approach to ischemic heart failure. J Nucl Cardiol. 2015 Apr;22(2):229-45. doi: 10.1007/s12350-015-0096-5. Epub 2015 Mar 3.

  PMID: 25733105 BACKGROUND

• Shah DJ, Kim HW, James O, Parker M, Wu E, Bonow RO, Judd RM, Kim RJ. Prevalence of regional myocardial thinning and relationship with myocardial scarring in patients with coronary artery disease. JAMA. 2013 Mar 6;309(9):909-18. doi: 10.1001/jama.2013.1381.

  PMID: 23462787 BACKGROUND

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Hosam H. Elaraby, PhD

  Professor at cardiovascular medicine department , assiut university

  STUDY DIRECTOR

Central Study Contacts

Ahmed A. Abdelmuty, MBBS

CONTACT

+20 01061035644; ahmed.attia.mogge@gmail.com

Shimaa S. Khidr, PhD

CONTACT

+20 01001346551; s.khidr@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: February 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: January 18, 2022

Record last verified: 2022-01