ECG Triggered Dual Source CT for Non-invasive Pre-operative Cardiac Imaging in Morbid Obese Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Coronary arterial disease is a risk factor for bariatric surgery and might be a predictor for later major adverse coronary events. Diagnosis of coronary arterial disease would thus be desirable for obese patients, however percutaneous angiography is an invasive procedure and associated with a certain morbidity in obese patients. In this study the investigators would like to assess whether dual source CT angiography can be used for diagnosis of coronary arterial disease in severely obese patients and which settings yield the best image quality.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

320 Multidetector Computed Tomography Prior to Coronary Artery Bypass Surgery

NCT01169948

Coronary Disease

WITHDRAWN

Imaging-based Diagnosis of Diffuse Coronary Artery Disease and Quantification of Cardiac Remodeling in Obesity

NCT03046823

Obesity

COMPLETED

Magnetocardiography (MCG) in Subjects Undergoing CT Angiography (CTA)

NCT00574561

Chest Pain

WITHDRAWN

Dual Energy Cardiac CT Data Collection and Evaluation

NCT05171764

Cardiovascular Diseases

COMPLETED

Optimizing Image Quality in Obese Patients Undergoing Coronary Computed Tomography (CT) Angiography

NCT00468195

Coronary Angiography Obesity Coronary Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Obesity is a major health problem in many countries and a major risk factor for cardiovascular disease. Extreme obesity can be treated with surgery, however these procedures are associated with a certain surgery-related morbidity which increases with comorbidities, in particular coronary diseases. Thus, preoperative cardiac risk assessment would be desirable, however percutaneous coronary angiography is an invasive procedure with problems and complications in obese patients. A non-invasive alternative would be coronary dual-.source CT angiography (CCTA), however little experience exists in the application of CCTA in morbid obese patients. This study would like to address the following issues:

1. Comparison of image quality of coronary CT angiography using a dual source CT from obese patients using a special protocol (140 kV, 350 mAs) with images from historical controls from normal weight patients with a standard protocol (120 kV, 330 mAs).
2. Prediction of major adverse coronary events. Patients with a coronary stenosis in CCTA will be followed for any major adverse coronary events (details see Outcomes)
3. Is it possible to detect myocardial fat by a reduced CT density. Images from obese patients will be compared to historical controls from normal patients. Furthermore, is the myocardial CT density correlated with the BMI of obese patients?
4. Optimisation of scan protocol. Increasing the scanning angle beyond the standard 90° will reduce the signal noise at the cost of temporal resolution. Various scanning angles with be tested for an optimal combination of signal noise and temporal resolution.
5. Does the long QT-syndrome improve after bariatric surgery? It is assumed that the long QT-syndrome is a consequence of fattening of the myocardia. Is it possible to see a reduction of myocardial fattening and thus an improvement of the long QT-syndrome with CT during the follow-up after bariatric surgery?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Morbid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A: standard protocol

Standard dual-source computed tomography coronary angiography protocol

Group Type ACTIVE_COMPARATOR

standard protocol

Intervention Type RADIATION

tube voltage: 120 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)

B: enhanced protocol

enhanced dual-source computed tomography coronary angiography protocol

Group Type EXPERIMENTAL

enhanced protocol

Intervention Type RADIATION

tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)

C: enhanced obesity protocol

enhanced obesity-mode dual-source computed tomography coronary angiography protocol

Group Type EXPERIMENTAL

enhanced obesity protocol

Intervention Type RADIATION

tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 180° (with two detectors in a 90° angle)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

standard protocol

tube voltage: 120 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)

Intervention Type RADIATION

enhanced protocol

tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)

Intervention Type RADIATION

enhanced obesity protocol

tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 180° (with two detectors in a 90° angle)

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

dual source computed tomography coronary angiography dual source computed tomography coronary angiography dual source computed tomography coronary angiography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* morbid obesity (BMI \>35 kg/m²)
* intention to undergo bariatric surgery
* increased risk for coronary artery disease (based on PROCAM score)

Exclusion Criteria

* kidney insufficiency (serum creatinine \>100 µmol/l, creatinine clearance \<50 ml/min)
* allergy to iodine containing contrast agents
* hyperthyroidism
* metformin medication
* pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No