No registrations found.
ID
Source
Brief title
Health condition
Coronary artery disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the registry is the event rate of MACE and all-cause mortality in a 12 month follow-up period
Secondary outcome
Quality of life
Background summary
Only small proportion of the 180 000 patients that are referred to a cardiologist each year in the Netherlands with complaints of angina pectoris or shortness of breath suffer from coronary stenosis in such a degree that revascularisation is required. To identify these patients, multiple diagnostic tests are available. Simple non-interventional imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out coronary artery disease. However, when coronary artery disease is present, coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis.
If coronary CT-scan shows no or mild non-flow restricting coronary artery disease, further diagnostic testing is not neccessary. In this registry-part of the iCORONARY trial, these patients are included in a registry in which we will assess outcomes and quality of life at various timepoints until 12 months after undergoing CCTA using questionnaires. Following these patients up ensures we obtain a ‘real-world’ estimate of the ability of CCTA to adequately triage patients with no or low CAD disease burden from patients with intermediate to severe CAD disease burden as practiced in the Netherlands. In other words, it provides us with an estimate of the ability of CCTA to effectively rule out CAD in need of further evaluation.
The primary objective of the registry is the event rate of MACE: all-cause mortality, aborted sudden cardiac death, myocardial infarction and unplanned hospitalization for chest pain leading to urgent revascularization. We hypothesize that the MACE and mortality rates will be very low, due to mild or absent coronary disease on the CCTA and the short follow-up duration.
This study consists of a randomized controlled trial and a patient registry. This is the registration of the patient registry. For the registration of the randomized controlled trial, see registration NL9492
Study objective
We hypothesize that the MACE and mortality rates will be very low, due to mild or absent coronary disease on the CCTA and the short follow-up duration.
Study design
- Week -2: screening and approaching of possible subjects (after referral for coronary CT-scan)
- Week -1: informing possible subject about study procedure (day of coronary CT-scan)
- Week 0: inclusion, informed consent, first (baseline) questionnaire
- 1 month: second questionnaire
- 3 months: third questionnaire
- 6 months: fourth questionnaire
- 12 months: fifth questionnaire
Inclusion criteria
- The subject is ≥ 18 years of age
- The subject is willing and able to provide informed consent and adhere to study rules and regulations and follow-up
- The subject has the clinical suspicion of having (recurrent) angina pectoris or an equivalent and suspected coronary artery disease, based on symptoms and signs, history, clinical examination and baseline diagnostic testing (e.g. ECG recording and laboratory tests) as described in the 2019 ESC guideline on chronic coronary syndromes.
- The subject has undergone ≥64 multidetector row coronary CTA as part of usual care deemed by the treating physician, which shows a CAD-RADS score of 0-2
Exclusion criteria
- The subject is suffering from unstable angina pectoris.
- The subject is suffering from decompensated congestive cardiac failure.
- The subject is suffering from a known non-ischemic cardiomyopathy.
- The subject has a history of PCI or coronary artery bypass grafting (CABG).
- The subject has had pacemaker or internal defibrillator leads implanted.
- The subject has a prosthetic heart valve.
- There is a severe language barrier.
- The subject participates in any other clinical trial that interferes with the current study.
- Clinical condition prohibiting subsequent interventional therapy as indicated by the results of the imaging procedures.
- The subject is or might be pregnant.
- The subject does not comply or is not able to comply to the imaging guidelines for the performance and acquisition of CCTA by the Society of Cardiac Computed Tomography (SCCT), including:
• The subject is suffering from a cardiac rhythm other than sinus rhythm.
• The subject is morbidly obese (Body Mass Index (BMI) > 40).
• The subject is not able to sustain a breath-hold for 25 seconds.
• The subject is unable to remain in supine position for at least 30 minutes.
• The subject has known allergies to or contra-indications to receiving an iodinated contrast agent. Contraindications to receiving an iodinated contrast agent: Glomerular Filtration Rate (GFR) < 45 ml/min/1,73m2 and if the subject is diabetic or has at least two risk factors for developing contrast induced renal failure a GFR < 60 ml/min/1,73m2.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9495 |
| Other | MEC-U : R21.026 |