Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
AAA annual growth rate over time |
AAA annual growth rate will be measured in AAA patients who switch from smoking cigarettes to using IQOS, and AAA patients who continue to smoke CC, as compared to AAA patients who had stopped smoking. Maximum minor-axis AAA diameter in mm will be measured. Annual growth rate will be calculated by annualizing the slope of the linear regression over the available diameter measurements. |
At 6-month intervals from baseline to 5 years |
|
| Secondary |
Period of time from diagnosis of the AAA until open surgical AAA treatment or AAA endovascular repair or AAA rupture |
The time from diagnosis of the AAA until open surgical AAA treatment or AAA endovascular repair or AAA rupture will be measured in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. |
From diagnosis of AAA to 5 years |
|
| Secondary |
Incidence of open surgical AAA treatment or AAA endovascular repair and AAA rupture |
The incidence of open surgical AAA treatment or AAA endovascular repair and AAA rupture will be measured in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue to smoke CC and AAA patients who had stopped smoking. Incidence rate will be calculated annually. |
From baseline to 5 years |
|
| Secondary |
Incidence of AAA growth above 5 mm within 6 months |
Incidence of AAA growth above 5 mm within 6 months will be measured in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. Incidence rate will be calculated annually by counting the number of patients with an increase in maximum minor-axis AAA diameter of more than 5 mm within 6 months. |
At 6-month intervals from baseline to 5 years |
|
| Secondary |
AAA patients with an overall maximum minor-axis AAA diameter of >55mm in male patients and >50mm in female patients |
The number of AAA patients with an overall maximum minor-axis AAA diameter >55mm in male AAA patients and >50mm in female AAA patients will be counted in AAA patients who switch from smoking CC to using IQOS, as compared to AAA patients who continue smoking CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Incidence of ischemic heart disease (IHD) in AAA patients |
Number of AAA patients with a diagnosis of IHD, IHD progression (by number of new myocardial infarction, stroke or death) or IHD related event annually. |
From baseline to 5 years |
|
| Secondary |
Incidence of chronic obstructive pulmonary disease (COPD) in AAA patients |
Number of AAA patients with a diagnosis of COPD, COPD progression (by disease stage) or a COPD related event annually. |
From baseline to 5 years |
|
| Secondary |
Incidence of hypertension in AAA patients |
Number of AAA patients with a diagnosis of hypertension, progression of their hypertension (by disease stage), or a hypertension related event annually. |
From baseline to 5 years |
|
| Secondary |
Incidence of peripheral arterial disease (PAD) in AAA patients |
Number of AAA patients with a diagnosis of PAD, PAD progression (by disease stage) or PAD related event annually. |
From baseline to 5 years |
|
| Secondary |
Incidence rate of other smoking-related diseases, and their related events, in AAA patients |
Number of AAA patients with adverse events related to the diagnosis of other co-morbidities, events related to the other co-morbidities. |
From baseline to 5 years |
|
| Secondary |
Urinary nicotine equivalents (NEQ) |
To measure nicotine exposure over time in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC, and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Systolic blood pressure |
This cardiovascular clinical risk endpoint (systolic blood pressure) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Diastolic blood pressure |
This cardiovascular clinical risk endpoint (diastolic blood pressure) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Body weight |
This cardiovascular clinical risk endpoint (body weight) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Waist circumference |
This cardiovascular clinical risk endpoint (waist circumference) will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
High sensitive C-reactive protein (hs-CRP) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Low density lipoprotein (LDL) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
High density lipoprotein (HDL) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Total Cholesterol (TC) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Triglyceride (TG) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Fasting blood glucose |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Hemoglobin A1c (HbA1c) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
White blood cell (WBC) and platelet counts |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
D-dimer |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Fibrinogen |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Total Antioxidant Capacity (TAC) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
11-dehydro-thromboxane B2 (11-DTX-B2) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
8-Epi Prostaglandin F2 Alpha (8-epi-PGF2a) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Metalloproteinase 2 (MMP- 2) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, patients who continue to smoke CC and patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Metalloproteinase 9 (MMP-9) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, patients who continue to smoke CC and patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Soluble inter-cellular adhesion molecule-1 (sICAM-1) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Apolipoprotein A1 (Apo A1) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Apolipoprotein B (Apo B) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Homocysteine (Hcy) |
This cardiovascular clinical risk endpoint will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) |
This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Total N-nitrosonornicotine (Total NNN) |
This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
2-cyanoethylmercapturic acid (CEMA) |
This biomarker of exposure to a tobacco smoke constituent will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Ankle-brachial index (ABI) |
The ABI will be measured in AAA patients who switch from smoking CC to using IQOS, AAA patients who continue to smoke CC, and AAA patients who had stopped smoking. |
From baseline to 5 years |
|
| Secondary |
Transcriptomic profile assessment in blood samples |
To evaluate differential changes in gene expressions, transcriptomics analyses will be performed on collected blood samples. Isolated RNAs will be applied to a gene chip that contains 54,000 transcripts. The gene chip will then be scanned using Affymetrix. The outcome measurements that will be reported are relative changes and relative fold changes in gene expressions in AAA patients who continue smoking cigarettes and those switching to IQOS. |
From baseline to 5 years |
|
| Secondary |
Proteomic profile assessment in plasma derived from blood samples |
To evaluate changes in selected protein concentrations, targeted proteomics analyses will be performed on plasma derived from collected blood samples. Proteins will be isolated from plasma and targeted proteomics analyses will be performed using liquid chromatography mass spectrometry (LC MS/MS) and antibody-based Luminex. The outcome measurements that will be reported are the concentrations of the selected proteins measured in AAA patients who continue smoking cigarettes and those switching to IQOS. |
From baseline to 5 years |
|
| Secondary |
Lipidomic profile assessment in plasma derived from blood samples |
To evaluate changes in selected ceramide concentrations, targeted lipidomics analyses will be performed on plasma derived from collected blood samples. Ceramides will be isolated from plasma and targeted lipidomics analyses will be performed using liquid chromatography mass spectrometry (LC MS/MS). The outcome measurements that will be reported are the concentrations of the selected ceramides measured in AAA patients who continue smoking cigarettes and those switching to IQOS. |
From baseline to 5 years |
|
| Secondary |
Lipidomic profile assessment in urine |
To evaluate changes in selected eicosanoid concentrations, targeted lipidomics analyses will be performed in urine. Eicosanoids will be isolated from urine and targeted lipidomics analyses will be performed using liquid chromatography mass spectrometry (LC MS/MS). The outcome measurements that will be reported are the concentrations of selected eicosanoids measured in AAA patients who continue smoking cigarettes and those switching to IQOS. |
From baseline to 5 years |
|
