Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Pain

Chest Pain

Precancerous Conditions

Neurologic Manifestations

All Drugs and Chemicals

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Imidacloprid

The participants in the intervention group will be provided with extended information of the advantages of the CT examination of the heart's arteries. This will be given to the participants both orally and written in form of a leaflet. In addition will they be given the opportunity for a visual go-through of their own calcium score images. After this they will be informed of the normal examination result.

The extended information consists out of an information leaflet and a visual go-through of the participants calcium score images. The patients are then given the normal examination result.

Extended information

Tone M Norekvaal, Professor

Chest pain is a common cause of visits in the Emergency Room and General Practice, and is most commonly connected as a symptom of coronary disease, as for instance angina pectoris and acute myocardial infarct. Approximately 75-80% of these patients are not diagnosed with coronary disease or other cardiac findings. However, many of these patients still report chest pain and worries about cardiac disease.

This study is based on patients that are referred to a CT-examination of the coronary arteries on the background of chest pain, where the CT-examination shows normal coronary arteries.

The study aims to evaluate whether providing an intervention to this group of patients has an effect on patient satisfaction, patient's worry of cardiac disease and incidence of chest pain.

The intervention group will be compared with a similar group going through the same CT-examination, but is receiving the examination result from their regular general practitioner (RGP), which is considered standard care.

The hypothesis is that patients with chest pain with no coronary findings receiving extended information before getting the normal examination results experience a better patient satisfaction than those receiving the examination result from their RGP.

This study is a randomized controlled study. Eligible patients going through a CT-examination of the heart's coronary arteries, Coronary CT Angiogram (CCTA) will after an informed consent be randomized into two groups, either the intervention group or standard care.

The intervention consists of extended information regarding the benefits of doing a CCTA, thereby emphasising the specificity and accuracy of the CCTA's ability to exclude coronary disease. After this, there will be given an opportunity of a visual go-through and explanation of CT-images. Then they will be informed of the examination result that shows normal coronary arteries.

Follow up is planned after one month, six months and twelve months, where the participants receive the same questionnaire as at baseline to fill out and return. The questionnaire consists of Seattle Angina Questionnaire and RAND-12, in addition to social demographic and clinical data, such as sex, height, weight and current medication.

Providing Patient Information and CT Examination Results

Providing Patients With Extended Information and Examination Results Immediately After a Diagnostic CT of the Coronary Arteries

Our primary outcome is to examine whether patients with chest pain with normal coronary arteries experience greater satisfaction with their treatment if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their RGP.

This is measured with 2 single items in Seattle Angina Questionnaire regarding satisfaction with treatment. Values range from 1-5, 1 is the lowest level of satisfaction, and 5 is the highest level of satisfaction. Greater satisfaction with treatment will be defined by a higher score at follow-up after 1 month.

In addition, there is a separate question of patients' trust in the CT examination measured with a VAS-scale , ranging from 1-10, 1 represents lowest possible degree of trust, and 10 represents highest possible degree of trust. Greater trust in the CT-examination is defined by higher scores at follow-up after 1 month.

To examine if patients report less worry of having a heart attack or sudden death after having a CT examination of the heart's arteries, when receiving extended information and the normal examination result immediately after the CT examination.

This is measured with a single item in Seattle Angina Questionnaire regarding worry of having heart attack or die suddenly. Values range from 1-5, 1 represents "worry all the time" and 5 represents "never worry". Less worry of having a heart attack or die suddenly will be defined by higher scores at follow-up after 1, 6 and 12 months.

To examine if patients with chest pain with normal coronary arteries report less chest pain and/or less use of health care services if they receive extended information and the examination results immediately after the CT examination compared to those who receive the examination result from their RGP.

This is measured with 2 single items in Seattle Angina Questionnaire. One item regards limitations in everyday activities because of chest pain. Values range from 1-5, 1 represents lowest level, and 5 represents highest level of function. The second item is about incidence of chest pain the last week. Values range from 1-5, 1 represents high incidence of chest pain and 5 represents no chest pain. Less chest pain is associated with higher scores at all times of follow up, compared to baseline.

In addition, clinical data regarding participants use of primary and secondary health care the last 4 weeks is collected at all times of follow-up and is compared to baseline data.

To examine whether patients with chest pain with normal coronary arteries experience greater satisfaction with their treatment if they receive extended information and the examination results immediately after the CT examination than those who receive the examination result from their RGP.

This is measured with 2 single items in Seattle Angina Questionnaire regarding satisfaction with treatment. Values range from 1-5, 1 is the lowest level of satisfaction, and 5 is the highest level of satisfaction. Greater satisfaction with treatment will be defined by a higher score at follow-up after 6 and 12 months.

Haukeland University Hospital

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Breast Neoplasms

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Breast Diseases

Skin Diseases

Anticoagulants

Other Dietary Supplements

Citric Acid

Sodium Citrate

Citrate

After signing the informed consent form, patients who meet all eligibility criteria will be enrolled in the Study. After execution of the CT scan the patient will be contacted to discuss the CT scan result. In case of high calcium score values, patients will be performing a cardiological medical examination, ECG, and further diagnostic investigations, as clinically indicated

Each enrolled patient performs:

* preventive clinical cardiology assessment visit, addressed to individualized risk profile assessment and addressed to chest CT scan.
* a blood sampling (1 citrate tube of 5 ml) will be done the same day just the chest CT scan and analyzed locally also for future research of biomarker discovery (single sample, for those patients who agree in ICF)
* CT scan

CT scan and blood sample collection

Daniela Trabattoni, MD

This is a no-profit, national, monocenter, retrospective, and prospective low-intervention study. It is a low-intervention study in terms of diagnostic additional procedure (CT scan). It is planned to recruit a maximum of 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at the European Institute of Oncology who meet all the inclusion and exclusion criteria. The aim of the Study is to analyze a population of breast cancer patients treated by adjuvant whole breast radiotherapy to identify the most important cardiovascular (CV) risk factors linked to coronary artery disease (CAD) development, in a cure-without-complications oncology strategy.

In the present study a pre-screening activity is planned, that will be conducted by the European Institute of Oncology (IEO) at the Division of Radiotherapy. It will be done to identify and select from the IEO's database about 100 women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy, from 2010 to 2017, and with a \> 5 years clinical Follow up (FU). All patients, who present pre-specified RT treatment, in terms of radiation exposure, and radiation protocol (IORT excluded as well as previous RT treatments), will be proposed to participate in the Study. The researcher of the IEO will contact by phone each identified patient (eligible patients) to request her interest in participating in the present study and to obtain her availability to be contacted by the Investigator of Centro Cardiologico Monzino (CCM) to define all aspects and activities planned in the protocol.

Patients who meet all eligibility criteria, after signing the informed consent form, at Centro Cardioogico Monzino, will be enrolled in the study. After execution of the CT scan the patient will be contacted to discuss the CT scan result. In case of high calcium score values, patients will be performing a cardiological medical examination, ECG, and further diagnostic investigations, as clinically indicated.

Women diagnosed with early-stage breast cancer and treated with adjuvant breast radiotherapy from 2010 to 2017 at European Institute of Oncology

Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer

Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT for Breast Cancer. A Gender-based Preventive Medicine Approach

Coronary calcium (CAC) assessment and its relationship with left-side or right-side breast radiation therapy and previously known cardiovascular risk factors. The quantification of CAC will be performed according to the Agatston score by multiplying the total CAC area in mm2 by a density factor ranging from 1 to 4 (1 for lesions with a density of 130-199 HU; 2 if the lesion has a density of 200-299 HU; 3 for lesions with a density of 300-399 HU; 4 for densities ≥400 HU)

Evaluate circulating markers, mostly related to radiation-induced oxidative stress and correlate them to previous CV events and CT data obtained. Patients will undergo a blood sample withdrawal focused on evaluation of albumin isoforms in human plasma and protein signatures.

Albumin thiolation: Mercaptoalbumin (HSA-SH) and thiolated albumin (+120 ± 2 Da, Thio-HSA) will be detected and their intensities used to calculate the relative abundances. Targeted Proteomics will be performed and relative quantitation will be expressed in Normalized protein expression (NPX), Normalized Protein eXpression, is Olink's arbitrary unit which is in Log2 scale. It is calculated from Ct values and data pre-processing (normalization) is performed to minimize both intra- and inter-assay variation. NPX data allows users to identify changes for individual protein levels across their sample set, and then use this data to establish protein signatures.

Incidence of CV events in relationship to left vs right-side breast radiation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Providing Patient Information and CT Examination Results	NCT03781661	Chest Pain Nonmalignant Co...	Extended inform...	18 Years - 80 Years	Haukeland University Hospital
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer	NCT05775822	Breast Cancer	CT scan and blo...	18 Years - 60 Years	Centro Cardiologico Monzino
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer	NCT05775822	Breast Cancer	CT scan and blo...	18 Years - 60 Years	Centro Cardiologico Monzino

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