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Obesity, MorbidNCT02802579

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

A study testing standard protocol, enhanced protocol and enhanced obesity protocol in people with Obesity, Morbid, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Morbid
What is being tested?
standard protocol, enhanced protocol and enhanced obesity protocol
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSwitzerland
Study dates
Dec 2007to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Cantonal Hospital St Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

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.

Read the detailed description

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
Obesity, Morbid
Being tested
standard protocol, enhanced protocol, enhanced obesity protocol
Keywords
obesity, dual source CT, coronary CT angiography, prognosis, bariatric surgery, gastric bypass surgery, coronary arterial disease, major adverse coronary event
Medical subject headings
Obesity, Morbid, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard protocolRadiation

    Also called dual source computed tomography coronary angiography

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

  • enhanced protocolRadiation

    Also called dual source computed tomography coronary angiography

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

  • enhanced obesity protocolRadiation

    Also called dual source computed tomography coronary angiography

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

Study groups in NCT02802579
Study groupRoleWhat they receive
A: standard protocolActive comparatorStandard dual-source computed tomography coronary angiography protocol
Receives: Radiation: standard protocol
B: enhanced protocolExperimentalenhanced dual-source computed tomography coronary angiography protocol
Receives: Radiation: enhanced protocol
C: enhanced obesity protocolExperimentalenhanced obesity-mode dual-source computed tomography coronary angiography protocol
Receives: Radiation: enhanced obesity protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Image quality

    Coronary arteries (with at least 1 mm diameter at their origin) were segmented according to the 15-segment model of the American Heart Association (Austen 1975). Subjective image quality was judged for each coronary artery segment on a 4-point scale (Leschka 2007) :

    1. = excellent;
    2. = good, minor artifacts;
    3. = fair, moderate artifacts but still diagnostic;
    4. = non-diagnostic

    Measured: 7 days

  2. coronary artery stenosis

    Significant coronary artery stenosis was defined as more than 50% narrowing of luminal diameter. Stenosis assessment was performed by a radiologist not involved in image quality assessment.

    Measured: 7 days

Secondary outcomes (4)

  1. Image noise

    Image noise was determined as the standard deviation of the attenuation value in a region of 1 sq cm that was placed in the ascending aorta. The average of the attenuation in the left and right coronary artery were used for further calculations.

    Measured: 7 days

  2. Signal-to-noise ratio (SNR)

    SNR was determined by dividing mean attenuation by image noise

    Measured: 7 days

  3. contrast-to-noise ratio (CNR)

    Vessel contrast was calculated as the difference in the mean attenuation (in Hounsfield units) between the contrast-enhanced vessel lumen and the mean attenuation in the adjacent perivascular tissue. Attenuations were measured in a region in the proximal segment of the right coronary artery and in the left main artery, and were defined as large as possible, whereas avoiding calcifications and plaques. CNR was calculated as vessel contrast divided by image noise (Husmann 2006, Lembcke 2004).

    Measured: 7 days

  4. Major adverse cardiovascular events (MACE)

    Any of the following events:

    • death
    • non fatal myocardial infarction
    • late revascularization with percutaneous coronary intervention
    • coronary artery bypass grafting

    Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2016 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02802579
Sponsor's protocol ID
RAD0701
Status last verified
Jun 2016
First submitted
14 Jun 2016
Last updated
17 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Austen WG, Edwards JE, Frye RL, Gensini GG, Gott VL, Griffith LS, McGoon DC, Murphy ML, Roe BB. A reporting system on patients evaluated for coronary artery disease. Report of the Ad Hoc Committee for Grading of Coronary Artery Disease, Council on Cardiovascular Surgery, American Heart Association. Circulation. 1975 Apr;51(4 Suppl):5-40. doi: 10.1161/01.cir.51.4.5. No abstract available.

    PubMed 1116248

  • Leschka S, Scheffel H, Desbiolles L, Plass A, Gaemperli O, Valenta I, Husmann L, Flohr TG, Genoni M, Marincek B, Kaufmann PA, Alkadhi H. Image quality and reconstruction intervals of dual-source CT coronary angiography: recommendations for ECG-pulsing windowing. Invest Radiol. 2007 Aug;42(8):543-9. doi: 10.1097/RLI.0b013e31803b93cf.

    PubMed 17620936

  • Husmann L, Alkadhi H, Boehm T, Leschka S, Schepis T, Koepfli P, Desbiolles L, Marincek B, Kaufmann PA, Wildermuth S. Influence of cardiac hemodynamic parameters on coronary artery opacification with 64-slice computed tomography. Eur Radiol. 2006 May;16(5):1111-6. doi: 10.1007/s00330-005-0110-4. Epub 2006 Jan 28.

    PubMed 16607499

  • Lembcke A, Wiese TH, Schnorr J, Wagner S, Mews J, Kroencke TJ, Enzweiler CN, Hamm B, Taupitz M. Image quality of noninvasive coronary angiography using multislice spiral computed tomography and electron-beam computed tomography: intraindividual comparison in an animal model. Invest Radiol. 2004 Jun;39(6):357-64. doi: 10.1097/01.rli.0000123316.10765.6c.

    PubMed 15167102

Questions about this trial

What is this clinical trial studying?

A study testing standard protocol, enhanced protocol and enhanced obesity protocol in people with Obesity, Morbid, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Image quality (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02802579, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.

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