Informed Consent for Coronary Angioplasty and Percutaneous Coronary Intervention (PCI)
Informed Consent for Coronary Angioplasty and Percutaneous Coronary Intervention (PCI)
Patient and Procedure Identification
Nature and Purpose of the Procedure
Coronary angiography is a diagnostic procedure in which a flexible catheter is inserted through a peripheral artery (radial artery at the wrist, or femoral artery at the groin) and advanced under fluoroscopic (X-ray) guidance to the coronary arteries. Iodine-based contrast dye is injected to visualize the coronary anatomy and identify areas of narrowing or blockage. If a significant stenosis (typically greater than 70% luminal diameter reduction) is identified and deemed appropriate for intervention, percutaneous coronary intervention (PCI) is performed: a guidewire is crossed through the stenosis, a balloon catheter is inflated to compress the plaque, and a bare-metal or drug-eluting stent is deployed to scaffold the vessel wall and maintain patency. The entire procedure typically takes 30 to 90 minutes.
Critical Antiplatelet Compliance Requirement
Following drug-eluting stent (DES) implantation, dual antiplatelet therapy (DAPT) with aspirin (75-100 mg daily) and a P2Y12 inhibitor (clopidogrel 75 mg, ticagrelor 90 mg twice daily, or prasugrel 10 mg daily) is mandatory for a minimum of 6 to 12 months, and in certain high-risk cases for up to 24 months. Premature discontinuation of DAPT without cardiology authorization substantially increases the risk of acute in-stent thrombosis, a potentially fatal event causing massive myocardial infarction. Patients must not stop or alter their antiplatelet regimen without explicit cardiologist approval, even if another physician recommends it for a separate procedure.
Material Risks and Potential Complications
Reasonable Alternatives
Expected Benefits
The primary expected benefit of coronary angiography is definitive visualization of the coronary anatomy to guide treatment decisions. If PCI is performed, the intended benefit is restoration of blood flow through the blocked or narrowed artery, which is expected to relieve angina symptoms, reduce myocardial ischemia, and in the setting of acute MI, limit myocardial damage and improve survival. Successful PCI with stent placement aims to restore normal coronary blood flow, reduce angina burden, improve exercise tolerance, and reduce the frequency of hospitalizations for chest pain.
Implant Registry and Stent Identification Card
Following stent implantation, you will receive a stent identification card documenting the stent manufacturer, model, size, and date of implantation. You must carry this card at all times and present it to any healthcare provider or emergency room physician who treats you. This information is critical for future procedures and medication management. Your stent details will also be registered with the facility's implant registry as required by accreditation standards.
Right to Refuse or Withdraw Consent
You have the right to refuse this procedure or withdraw your consent at any time before the procedure begins without penalty or adverse effect on your medical care. Your physician will discuss alternative management strategies with you if you choose not to proceed. In emergency situations (e.g., acute STEMI), delay in proceeding may substantially increase the risk of permanent heart muscle damage or death, and this context will be explained to you.
Questions and Understanding Confirmation
I confirm that I have had the opportunity to read this consent form carefully and ask questions of my cardiologist. All my questions have been answered to my satisfaction. I understand the importance of dual antiplatelet therapy compliance following stent implantation. I believe I am making an informed and voluntary decision.
Language Access and Interpreter Services
If English is not your primary language or if you require assistance communicating, a qualified medical interpreter is available to you at no cost. Please notify your care team immediately if you require interpreter services. You have the right to receive this consent document in your primary language before signing.
Copy of Consent Acknowledgment
I acknowledge that I have been offered a signed copy of this informed consent form for my own records. I understand I may request an additional copy at any time from the facility or clinical records department.
Patient Declaration and Authorization
I have been informed of the nature of coronary angiography and PCI, the expected benefits, the material risks outlined above, and the available alternatives including medical therapy and surgery. I understand the critical importance of adherence to dual antiplatelet therapy following stent implantation and the life-threatening consequences of premature discontinuation. I consent to proceed with the procedure and authorize the cardiologist to perform any additional interventions required to achieve a safe and effective result. I understand that no guarantee of outcome has been made.