|Principal Investigator: Robert Paine III|
|Keywords: Respiratory , COPD , Emphysema , Cardiology , Heart failure , Cardiopulmonary||Department: Pulmonary|
|IRB Number: 00125520||Co Investigator: Richard Kanner|
|Specialty: Cardiology, Pulmonary|
|Recruitment Status: Not yet recruiting|
SPIROMICS II currently includes no cardiovascular (CV) phenotyping other than self-reported medical history. CV risk factor assessment is limited to gender, smoking, and blood pressure. The SPIROMICS Heart Failure Ancillary Study will add gold-standard cardiac phenotyping included echocardiography with exercise, cardiopulmonary magnetic resonance imaging (MRI), plethysmography (in a subset), cardiac risk factors, and coronary artery calcium measures.
Specific Aim 1: Machine-learned subtypes of emphysema on CT are associated with specific alterations in cardiac structure and function, which vary from cor pulmonale to LV diastolic dysfunction
Specific Aim 2: Participants with segmental airway variants have abnormal RV structure and function
Specific Aim 3: Symptomatic smokers have signs of increased LV afterload and LV diastolic dysfunction.
All ever smokers participating in SPIROMICS II Visit 5 at participating sites are eligible for SPIROMICS Heart Failure Ancillary Study
Exclusion criteria of echocardiography with exercise
The exercise protocol involves exercise for 3 minutes at 20 Watts followed by 3 minutes at 40 Watts on a recumbent bicycle. The level of exercise is approximately equal to or less than the 6MWT. Hence the exclusion criteria follow those for the 6MWT. In addition, recent pulmonary and CVD events and angina are temporary exclusion criteria for the visit, as outlined below. Similar to precautions for the 6MWT, there is an on-site MD and available crash cart in case of emergencies.
Exclusion criteria of the cardiopulmonary MRI
Participants will be screened for MRI safety. Usually this is a two-part screen involving 1) the study exclusion criteria, and 2) the local MRI scanning facility screening form, which may be slightly different. Exclusion on the basis of either form exclude the participant from the MRI. The major exclusion criteria are metal in the body that is MR-incompatible (e.g. defibrillator, certain types of metal implants). In addition, self-reported claustrophobia is an exclusion criterion for the MRI.
Exclusion criteria for the metronome breathing
The metronome breathing protocol involves breathing at 40 breaths per minute for 30 seconds before the MRI (repeated if the participant is not following directions well) and at the end of the MRI protocol. The level of exertion is similar to or less than spirometry. Hence the exclusion criteria follow those for the spirometry and the visit overall, i.e., recent pulmonary and CVD events and angina are temporary exclusion criteria. Participants can stop the test at any time and those who are unable to complete it before the MRI will be excluded from attempting it in the MRI.
Exclusion criteria for gadolinium
Participants with a history of gadolinium allergy and eGFR>45 will be excluded from gadolinium administration, the latter to due to risk of nephrogenic systemic fibrosis in those with severe CKD. If the participant’s eGFR is >60, then the measurement must be obtained within 30 days of gadolinium administration; if the eGFR is 45-60, then it must be obtained within 2 days of gadolinium administration.
Temporary exclusion criteria for SPIROMICS HF Visit
Temporary exclusion criteria are events, diseases, or treatments that require a waiting period to elapse before a participant can have the in-person visit. SPIROMICS HF will use the same temporary exclusion criteria as for Visit 5. The Modified Temporary Exclusion Criteria (mTEC) data collection form should be completed during the scheduling phone call to best determine if a waiting period is needed prior to scheduling the participant for the SPIROMICS HF visit.
Participants who present with a pulmonary or HF exacerbation, either solely participant-identified or that has been clinically treated, in the last six weeks can have their study visit once the six-week window has passed. Participants who present with an upper respiratory infection, either solely participant-identified or that has been clinically treated, in the last six weeks can have their study visit once the six-week window has passed.
Participants who present with current use of acute antibiotics or steroids can have their study visit ≥30 days after discontinuing acute antibiotics/steroids. This does not apply to participants who are on chronic prednisone therapy of <10 mg per day or <20 mg every other day or participants who are currently on chronic, prophylactic, or suppressive antibiotic therapy.
Participants who present with a myocardial infarction or eye, chest or abdominal surgery within six weeks can have their study visit after the six-week window has passed. Study coordinators should consult with the site principal investigator prior to scheduling these participants.
Female participants who present <3 months after giving birth will be asked to reschedule their visit until three months have passed since the birth.