Angina may persist or recur in patients treated by coronary angioplasty. The angioplasty involves a balloon treatment to open a blocked heart blood vessel and usually a stent (thin metal tube) is placed. Stents do not always improve symptoms and may make symptoms worse. Sometimes a drug-eluting-balloon is used instead of a stent. This balloon coats the inside of the blood vessel to prevent re-narrowing. Research is needed to clarify the causes of ongoing angina and its impact on patients and the NHS, and to identify which patients will or will not benefit from a stent (hence avoiding over-treatment in the future). We plan a 5-year UK-wide multicenter study involving up to 600 patients with angina undergoing coronary angioplasty (with or without a stent). They will initially have a heart MRI scan. We will assess what might influence the recurrence of angina in the year after the angioplasty procedure. We will measure small blood vessel function in the heart and the amount of plaque persisting after PCI. Patients who report angina after coronary angioplasty usually have a second invasive angiogram. Instead, we will invite patients to have a heart MRI scan allowing us to also assess whether this scan might be more useful than a repeat angiogram in guiding clinical care. We will collaborate with life scientists, mathematicians, statisticians, and health economists to better understand causes and health economic implications of angina arising after coronary angioplasty procedures.
Background: Prior studies indicate that potentially one in three patients may experience angina within 12 months of undergoing percutaneous coronary intervention (PCI). Hypothesis: 1) Diffuse coronary atherosclerosis and/or microvascular dysfunction impair myocardial blood flow (MBF) leading to angina post-PCI. Design: A 5-year interdisciplinary program with 3 scientific work-packages (WPs): 1) Clinical, 2) Systems medicine, and 3) Health Economics. WP1) Cohort study In 4 or more centers in the United Kingdom, 600 patients with angina will undergo stress/rest perfusion cardiovascular magnetic resonance (CMR) imaging with inline pixel-mapping of MBF (ml/min/g) and then coronary physiology measured during PCI. Patient reported outcome measures will be collected routinely during follow-up to 12 months. Primary outcome: Adjudicated, residual angina (Seattle Angina Questionnaire Angina Frequency (SAQ-7-AF) score \<90). Nested case-control study: stress perfusion CMR (MBF culprit artery territory, primary outcome) in approximately 200 patients reporting residual angina and 50 consecutive asymptomatic controls (all post-PCI). Clinically indicated coronary angiography including physiology tests (change from baseline measurement) and acetylcholine testing will be undertaken in approximately 120 patients. WP2) Systems medicine (n=600) using biostatistics to identify multivariable baseline associates (clinical, coronary physiology, haemodynamics, circulating biomarkers (DNA, RNA, protein) of the SAQ-7-AF score (range 0 (Severe) - 100 (no angina)) post-PCI. WP3) Health economics of NHS resource utilization and value of information (VoI) modelling to design stratified medicine trials. Value: Identification of mechanisms to inform downstream diagnostic and therapeutic strategies for angina post-PCI.
Study Type
OBSERVATIONAL
Enrollment
600
Observational diagnostic tests will include adenosine-stress perfusion cardiovascular magnetic resonance imaging before undergoing percutaneous coronary intervention.
Invasive coronary function tests using a diagnostic guidewire (PressureWire-X, Abbott), thermodilution, intravenous or intracoronary infusion of adenosine and intracoronary infusions of acetylcholine.
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Golden Jubilee National Hospital
Clydebank, Dunbartonshire, United Kingdom
University Hospital Hairmyres
East Kilbride, Lanarkshire, United Kingdom
Leeds General Infirmary
Leeds, Yorkshire, United Kingdom
Residual angina after percutaneous coronary intervention.
Residual angina post-PCI, defined as adjudicated, angina (Seattle Angina Questionnaire Angina Frequency (SAQ-7-AF) score \<90) occurring within one year of percutaneous coronary intervention.
Time frame: From enrolment to 12 months
Angina
Angina severity will be assessed using the Seattle Angina Questionnaire Summary Score.
Time frame: From enrolment to 12 months
Myocardial perfusion reserve
Myocardial perfusion reserve (MPR) within the distribution of the target coronary artery/ies revealed by cardiovascular magnetic resonance (CMR) imaging.
Time frame: From enrolment to 12 months
Fractional flow reserve post-percutaneous coronary intervention
Fractional flow reserve after percutaneous coronary intervention, reflecting the success of the procedure.
Time frame: 24 hours
Coronary flow reserve after percutaneous coronary intervention
Coronary flow reserve (CFR) post-PCI. Coronary flow reserve takes account of adenosine-mediated vasodilatation of the coronary artery and microcirculation. A CFR \<2.0 is abnormal, a CFR 2.0-\<2.5 is impaired and a CFR\>2.5 is normal.
Time frame: 24 hours
Index of microvascular resistance after percutaneous coronary intervention
Index of microvascular resistance (IMR) post-PCI. IMR reflects adenosine-mediated minimal microvascular resistance. An IMR \>=25 is abnormal.
Time frame: 24 hours
Microvascular dysfunction after percutaneous coronary intervention
Microvascular dysfunction is defined as a CFR\<2.5 and/or an IMR\>=25 post-PCI.
Time frame: 24 hours
Health-related quality of life
Health-related quality of life will be assessed using the EuroQol-5D 5 Level (5L) questionnaire. EQ-5D-5L is a health status questionnaire that measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Time frame: From enrolment to 12 months
Physical function
The Duke Activity Status Index (DASI) is a self-administered questionnaire with a 12-item scale that estimates physical functional capacity, cardiorespiratory function and metabolic equivalents (METs).
Time frame: From enrolment to 12 months
Illness perception
Brief Illness Perception Questionnaire (BIPQ) is a nine-item scale that measures the cognitive and emotional representations of illness.
Time frame: From enrolment to 12 months
Anxiety and depression
Patient Health Questionnaire-4 (PHQ-4) is a self-reported questionnaire to assess for anxiety and depression over the last 2 weeks. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety.
Time frame: From enrolment to 12 months
Productivity loss
The Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) is a generic tool to measure productivity losses.
Time frame: From enrolment to 12 months
Fraility
The Rockwood Clinical Frailty Scale (CFS) is a tool to summarize the overall level of fitness or frailty of an older individual.
Time frame: From enrolment to 12 months
Serious adverse events
Serious adverse events (SAE) post-enrolment will be assessed using electronic health records without the need for participant contact. The SAE of interest are pre-specified in the protocol. Where e-health records are not an option, then an annual contact with the participant should be undertaken to assess for SAE. The final visit is defined as when the last participant has completed 12 months follow-up. The minimum duration of follow-up will be 12 months and the maximum duration of follow-up is anticipated to be up to 48 months. Longer term follow-up to 20 years will be undertaken using electronic health record linkage.
Time frame: From enrolment to 12 months
Low density lipoprotein
Abnormal lipid metabolism, and hyperlipidemia, mediate atherogenesis. The circulating concentrations of low density lipoprotein, a proatherogenic lipid, will be assessed.
Time frame: From enrolment to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.