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

NCT04247698 | Unknown

• 1 other identifier: HDF
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Definition of the prognostic value of vasodilator stress and inotropic stress-CMR in patients with chronic CAD and a history of CABG.

  1 year

• Evaluation of the diagnostic accuracy of hemodynamic forces and assessment of the relationship to inducible wall motion abnormalities and perfusion defects.

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71516, Egypt

RECRUITING

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

• Amr Youssef, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ayat Abdelgalil, Msc.

CONTACT

+2 01144478313; soze2080@gmail.com

Hatem Helmy, MD

CONTACT

+2 01005212162; hatem19652007@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: January 7, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)