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SUBJECTS UNDERGOING FLUOROSCOPY Possible High Risk from Fluoroscopy Exposure (total radiation exposure during one year of the study >1500 mrem)
Coronary Angiography (randomized to PCI or chest x-ray and surgery) There are some risks from the x-rays used to diagnose your heart condition and for your treatment. These x-rays will expose you to radiation. If you live in the US, you receive about 300 millirem of radiation each year. It comes from space and the earth around you. This is called "background radiation." A "millirem" (mrem) is a unit used to measure doses of radiation. The radiation dose to your whole body from your examination will be about 400 mrem. The risk of harm from this amount of radiation is low. If you have more procedures that expose you to radiation, this risk will go up. Radiation exposure during stent placement may be much greater. Much of the radiation will be to local areas of the skin. If procedures take longer than expected, it is possible that injury to the skin can occur. Symptoms of injury to the skin may take time to develop. If you notice hair loss or redness of the skin, inform your doctor or a member of the research team at once. [Grade 6.9]
Coronary Angiography and Intervention There are some risks from the x-rays used to diagnose your heart condition and for your treatment. These x-rays will expose you to radiation. If you live in the US, you receive about 300 millirem of radiation each year. It comes from space and the earth around you. This is called "background radiation." A "millirem" (mrem) is a unit used to measure doses of radiation. The radiation dose to your whole body from your examination and your treatment will be about 1900 mrem. If you have 1500 mrem, your risk of harm might be as high as 1 in 1000. If you have more procedures that expose you to radiation, your risk will go up. Risks of harm may include getting cancer or changes in your genes. You may need to have other x-rays or scans for your care. Your doctors will explain the risks of the other x-rays or scans. Most of the radiation is to local areas of the skin. It is possible that the risk of injury to the skin is somewhat higher. The procedure may take longer than planned. If this happens, the radiation may cause serious injury to exposed areas of your skin. Symptoms may take time to develop. If you notice hair loss or redness of the skin, inform your doctor or the researcher at once. [Grade 6.2]
Fluoroscopy (dual-lead pacemaker implant, chest, 30 min) There are some risks from the x-rays required for the implantation of your pacemaker. These x-rays will expose you to radiation. If you live in the US, you receive about 300 millirem of radiation each year. It comes from space and the earth around you. This is called "background radiation." A "millirem" (mrem) is a unit used to measure doses of radiation. The radiation dose to your whole body from each of these is about as follows: Chest x-rays (2 views) - 12 mrem Fluoroscopy - 580 mrem The risk of harm from this amount of radiation is low. If you have more procedures that expose you to radiation, this risk will go up. [Grade 6.2]
Fluoroscopy (general risk statement to be added to the primary risk statement for all studies with potential for high fluoroscopy exposure, » 75 rem to skin) Most of the radiation is to local areas of the skin. It is possible that the risk of injury to the skin is somewhat higher. The procedure may take longer than planned. If this happens, the radiation may cause serious injury to exposed areas of your skin. Symptoms may take time to develop. If you notice hair loss or redness of the skin, inform your doctor or the research team at once. [Grade 7.2]

SUBJECTS UNDERGOING FLUOROSCOPY

Possible High Risk from Fluoroscopy Exposure
(total radiation exposure during one year of the study >1500 mrem)

Coronary Angiography
(randomized to PCI or chest x-ray and surgery)

There are some risks from the x-rays used to diagnose your heart condition and for your treatment. These x-rays will expose you to radiation. If you live in the US, you receive about 300 millirem of radiation each year. It comes from space and the earth around you. This is called "background radiation." A "millirem" (mrem) is a unit used to measure doses of radiation. The radiation dose to your whole body from your examination will be about 400 mrem. The risk of harm from this amount of radiation is low. If you have more procedures that expose you to radiation, this risk will go up. Radiation exposure during stent placement may be much greater. Much of the radiation will be to local areas of the skin. If procedures take longer than expected, it is possible that injury to the skin can occur. Symptoms of injury to the skin may take time to develop. If you notice hair loss or redness of the skin, inform your doctor or a member of the research team at once. [Grade 6.9]

Coronary Angiography and Intervention

There are some risks from the x-rays used to diagnose your heart condition and for your treatment. These x-rays will expose you to radiation. If you live in the US, you receive about 300 millirem of radiation each year. It comes from space and the earth around you. This is called "background radiation." A "millirem" (mrem) is a unit used to measure doses of radiation. The radiation dose to your whole body from your examination and your treatment will be about 1900 mrem. If you have 1500 mrem, your risk of harm might be as high as 1 in 1000. If you have more procedures that expose you to radiation, your risk will go up. Risks of harm may include getting cancer or changes in your genes. You may need to have other x-rays or scans for your care. Your doctors will explain the risks of the other x-rays or scans. Most of the radiation is to local areas of the skin. It is possible that the risk of injury to the skin is somewhat higher. The procedure may take longer than planned. If this happens, the radiation may cause serious injury to exposed areas of your skin. Symptoms may take time to develop. If you notice hair loss or redness of the skin, inform your doctor or the researcher at once. [Grade 6.2]

Fluoroscopy
(dual-lead pacemaker implant, chest, 30 min)

There are some risks from the x-rays required for the implantation of your pacemaker. These x-rays will expose you to radiation. If you live in the US, you receive about 300 millirem of radiation each year. It comes from space and the earth around you. This is called "background radiation." A "millirem" (mrem) is a unit used to measure doses of radiation. The radiation dose to your whole body from each of these is about as follows:

Chest x-rays (2 views) - 12 mrem
Fluoroscopy - 580 mrem

The risk of harm from this amount of radiation is low. If you have more procedures that expose you to radiation, this risk will go up. [Grade 6.2]

Fluoroscopy
(general risk statement to be added to the primary risk statement for all studies with potential for high fluoroscopy exposure, » 75 rem to skin)

Most of the radiation is to local areas of the skin. It is possible that the risk of injury to the skin is somewhat higher. The procedure may take longer than planned. If this happens, the radiation may cause serious injury to exposed areas of your skin. Symptoms may take time to develop. If you notice hair loss or redness of the skin, inform your doctor or the research team at once. [Grade 7.2]