Hemodynamic Forces at Rest and Stress vs. Adenosine and Dobutamine Stress Cardiac Magnetic Resonance (CMR)

Prognostic Value of Hemodynamic Forces at Rest and Stress Compared to Adenosine and Dobutamine Stress Cardiac Magnetic Resonance

Stress perfusion CMR has recently considered as one of the methods of choice for establishing the diagnosis of CAD based on its high diagnostic accuracy, lack of ionizing radiation as well as its ability to simultaneously assess the cardiac function, myocardial perfusion, and viability, however, there are some concerns on its suitability for assessment of myocardial perfusion in patients after coronary artery bypass graft surgery who suffer from recurrent angina. The study of hemodynamic forces offers a promising tool for further understanding of the interplay between the myocardium and blood as well as the mechanisms of cardiac filling. This work represents a retrospective follow up study of CMR data, available on CMR-database, from 112 patients with previous coronary artery bypass grafting (CABG) performed around 10 years before the initial CMR examination. The study subjects underwent stress CMR testing; using both stressors; dobutamine and adenosine (done on two separate occasions). Injection of gadolinium contrast medium for late gadolinium enhancement was done with adenosine stress testing for late gadolinium enhancement (LGE). Offline analysis of these data will be done with the use of dedicated software for assessment for myocardial ischemia together with quantitative measurements of the hemodynamic forces with the help of dedicated software (QStrain version 1.3.0.79; Medis, Leiden, the Netherlands).

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease

Detailed Description

In total 112 patients who underwent coronary artery bypass surgery (CABG) subjected to stress CMR examination on two separate occasions with both stressors; dobutamine and adenosine for assessment of myocardial ischemia as result of typical /atypical angina pectoris. The results from dobutamine (namely, detection of wall motion abnormalities) and adenosine stress CMR (namely, detection of perfusion abnormalities) will be compared with the values obtained from the measures of the hemodynamic forces of the LV (i.e., changes in the intraventricular pressures during systole and diastole). The dimensionless root mean square (FRMS) is computed over the entire heartbeat as a measure of the overall force amplitude. In addition, LV global longitudinal strain (GLS) and LV global circumferential strain (GCS) will be measured using a CMR feature tracking techniques. The expected results are as follows: Dobutamine wall motion analysis in combination with perfusion imaging has the highest diagnostic accuracy for the detection of ischemia in patients after bypass surgery and outperforms pure dobutamine wall motion or perfusion analysis and adenosine perfusion. Whereas, perfusion imaging with both stressors reflects the extent of ischemia more precisely than wall motion analysis. Nevertheless, assessment of hemodynamic forces adds to the diagnostic accuracy as well as the prognostic value of stress CMR in post-CABG patients, in whom stress testing with either or both stressors might fail to precisely define myocardial ischemia or reflect an associated subtle cardiac dysfunction.

• Study Type: Observational
• Enrollment (Anticipated): 112

Contacts and Locations

• Study Contact: Name: Ayat Abdelgalil, Msc.; Phone Number: +2 01144478313; Email: soze2080@gmail.com
• Study Contact Backup: Name: Hatem Helmy, MD; Phone Number: +2 01005212162; Email: hatem19652007@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71516
    • Recruiting
    • Assiut University
    • Contact: Ayat Abdelgalil, Msc.; Phone Number: +2 01144478313; Email: soze2080@gmail.com
    • Contact: Hatem Helmy, MD; Phone Number: +2 01005212162; Email: hatem19652007@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population are known to have coronary artery disease and underwent revascularization therapy via bypass surgery around 10 years before the initial CMR examination. Those presented with manifestations of recurrent post-CABG angina, with either typical or atypical presentation. Each patient had two CMR examinations on two occasions using both dobutamine and adenosine stress agents.

Description

Inclusion Criteria:

• Patients with established CAD and underwent coronary artery bypass graft surgery (CABG) performed around 10 years before the initial CMR examination. Who presented to CMR examination because of recurrent typical/ atypical angina.

Exclusion Criteria:

• All patients that were not able to withstand the condition of CMR examination
• Patients who had contraindications to the stressor agents used in stress CMR were not included in the analysis (i.e. bronchial asthma, high degree heart-block)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of hard and soft cardiac events and their relation to initial positive or negative Stress-CMR-test.	Hard cardiac outcomes are defined defined as deaths that are attributed to coronary artery disease, and non-fatal myocardial infarction. While soft events are defined as angina, or repeat revascularization for progressive coronary artery disease.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Definition of the prognostic value of vasodilator stress and inotropic stress-CMR in patients with chronic CAD and a history of CABG.	The capability of both stressors to detect precisely the presence recurrent ischaemia in patients with CAD on both CMR examinations	1 year
Evaluation of the diagnostic accuracy of hemodynamic forces and assessment of the relationship to inducible wall motion abnormalities and perfusion defects.	The power of how much the analysis of hemodynamic forces in comparison to adenosine and dobutamine to precisely detect ischaemic changes in either positive and negative stress CMR in such patients	1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Amr Youssef, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: HDF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No