Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02173470
Other study ID # NL47293.041.13
Secondary ID 837001403
Status Terminated
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date June 2020

Study information

Verified date June 2020
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess if information about aortic calcification obtained from routine preoperative ultra low-dose chest CT lowers the postoperative stroke rate in patients undergoing heart surgery by optimizing surgical strategy compared to the normal work-up with a conventional chest X-ray.


Description:

During heart surgery the aorta is clamped to initiate cardiopulmonary bypass. This may crush aortic calcifications causing them to embolize to the brain causing a stroke which is a devastating complication for the patient. A chest X-ray is routinely performed prior to heart surgery. It provides no information about aortic calcification. Imaging by a chest computed tomography (CT) scan provides detailed information on aortic calcification but has higher radiation exposure and thus is not used routinely. Recently iterative reconstruction (IR) techniques have become available that allow chest CT to be performed at markedly reduced dose with retained image quality. Routine use of low dose chest CT with IR prior to heart surgery may identify patients with a severely calcified aorta in which the surgery may subsequently adapted to minimize or avoid aortic manipulation which may reduce stroke rate.

In this multicenter randomized controlled clinical trial the effect of preoperative chest CT on postoperative stroke is investigated. In total 1724 patients will be included of whom 862 patients will receive an additional CT to standard care and 862 patients will receive routine care.


Recruitment information / eligibility

Status Terminated
Enrollment 866
Est. completion date June 2020
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years old or older

- Scheduled to undergo heart surgery

- Provide written informed consent

Exclusion Criteria:

- Patient not meeting inclusion criteria

- Pregnant women

- Scheduled to undergo transcatheter aortic valve insertion procedure (since these patients receive a standard preoperative CT)

- Chest or cardiac CT in the past three months

- Emergency surgery

- Concomitant or previous participation in a study that prohibits the patient from participating in a study that exposed the patient to radiation

- Unwillingness to be informed about unrequested findings on the CT scan

Study Design


Related Conditions & MeSH terms


Intervention

Other:
CT scan
The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.

Locations

Country Name City State
Hungary Heart and Vascular Center Semmelweis University Budapest
Netherlands Erasmus Medical Center Rotterdam
Netherlands University Medical Center Utrecht Utrecht

Sponsors (2)

Lead Sponsor Collaborator
UMC Utrecht ZonMw: The Netherlands Organisation for Health Research and Development

Countries where clinical trial is conducted

Hungary,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative stroke Percentage of patients suffering from in-hospital postoperative stroke (central neurological defect that either recovers spontaneously or is permanent) after heart surgery. Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary Altered surgical approach Percentage of patients in which the surgical approach is altered based on information derived from the preoperative chest CT. The surgery will take place the day after hospital administration.
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05621980 - Finger Movement Training After Stroke N/A