Acute Care Cardiovascular Trials | Ictaro Blog

A crisis measured in minutes

Every day, cardiovascular disease accounts for more than 42,500 deaths across Europe. That is not a statistic to absorb slowly — it is a number that accrues while clinical teams are working, while researchers are designing protocols, and while sponsors are deciding where to invest.

A significant proportion of those deaths are acute. A STEMI patient arrives at the emergency department with a blocked coronary artery. A patient with acute decompensated heart failure is deteriorating on the ward. Someone in cardiogenic shock needs a decision made in the next ten minutes. These are not the patients who attend outpatient clinics and return for follow-up visits. These are patients in the middle of a crisis — and in many cases, the window for intervention, and for research, is extremely narrow.

This is the territory of acute care cardiovascular trials. And it is, by some distance, the most operationally complex area of cardiovascular research.

What makes acute care trials different

Most clinical research is built around a relatively predictable rhythm. Patients are screened, consented, and enrolled over days or weeks. Visits are scheduled. Protocols are followed in controlled conditions.

Acute care cardiovascular trials operate under entirely different constraints. The patient population — those presenting with STEMI, NSTEMI, acute coronary syndrome, acute heart failure, or cardiogenic shock — is by definition unpredictable. Recruitment happens in the ambulance, emergency department or coronary care unit, often under time pressure, sometimes when the patient is not fully conscious or capable of providing standard informed consent. Treatment has to begin immediately, often before paperwork is complete.

This is not a variation on standard trial management. It requires a fundamentally different approach: 24/7 research coverage at sites, consent frameworks that account for emergency settings, protocols that are genuinely compatible with clinical workflows, and operational infrastructure that can respond at the same speed as the clinical team.

Without all of that in place, the trial simply will not enrol. And if it does not enrol, the evidence does not get generated.

Why the research gap exists — and why it matters

Despite the scale of the problem, acute cardiovascular conditions remain underserved in the research pipeline. This is not because the science is absent. The pathophysiology of acute MI, the mechanisms of cardiogenic shock, and the drivers of acute heart failure decompensation are well understood. The therapeutic targets are there.

The gap is operational. Running a trial in the acute care setting requires infrastructure, expertise, ambulance- and site relationships that most contract research organisations have not built — because it is easier, and more commercially predictable, to run trials in stable, chronic populations.

The consequences are real. Therapies developed in stable populations may not translate. Guidelines built on evidence from stable patients are applied to acute ones. And the patients who arrive in the emergency department — the ones whose outcomes are most time-sensitive — receive care informed by data that does not fully represent them.

It is also worth noting that this is not a small patient group. Acute cardiovascular events account for a significant proportion of all cardiovascular mortality and a disproportionate share of hospital admissions. The burden is large. The evidence base, relative to that burden, is thin.

What it actually takes to run these trials well

Acknowledging the challenge is straightforward. Solving it operationally is considerably harder. In our experience at ictaro, running acute care cardiovascular trials well requires getting several things right simultaneously.

In the pre-hospital setting, that complexity increases significantly. Ambulance services may involve dozens or even hundreds of clinicians who all need protocol training, must be able to manage informed consent correctly in a high-pressure environment, and are expected to complete study documentation accurately. On top of that, ambulances often serve multiple hospitals, creating additional logistical and administrative complexity across sites.

Site selection that goes beyond willingness

Not every hospital that treats acute cardiovascular patients is equipped to participate in research on them. A site needs 24/7 research coverage — not in principle, but in practice. It needs a cath lab or coronary care unit that is accessible around the clock. It needs clinical staff and ambulance teams who understand the protocol and have the time and inclination to implement it without disrupting patient care. Identifying sites that genuinely meet these criteria, rather than simply expressing interest, is one of the most consequential decisions in the feasibility process.

Consent frameworks designed for the acute setting

Standard informed consent assumes a patient who is conscious, able to read, and has time to consider their decision. In acute cardiovascular research, none of these assumptions may hold. Emergency consent, witnessed consent, and exception from informed consent (EFIC) frameworks exist for precisely this reason — but they vary by country, require specific regulatory preparation, and need to be built into the protocol from the outset. Getting this wrong does not just create regulatory problems; it creates real ethical ones.

Protocol design that fits the clinical workflow

A protocol that requires five study-specific procedures before a patient can be randomised will not work in a STEMI pathway where the clock starts at first medical contact. Acute care protocols need to be designed in close collaboration with the clinical teams running them — understanding exactly how patient management unfolds from arrival to treatment, and building the research procedures around that reality rather than despite it.

Operational infrastructure that matches the pace

A patient enrolled at 2am on a Saturday still needs the same quality of data capture, randomisation support, and IMP management as one enrolled on a Tuesday afternoon. Round-the-clock operational coverage, clear escalation pathways, and a project management team with genuine experience in acute settings are not optional extras — they are prerequisites.

The opportunity ahead

None of this is an argument that acute care cardiovascular trials cannot be done. They can — and they are being done, with meaningful results. Recent work in acute coronary syndromes, cardiogenic shock, and pre-hospital resuscitation has demonstrated that it is possible to generate robust evidence in these settings when the operational infrastructure is right.

The cardiovascular landscape over the coming decades will only intensify the urgency. An ageing European population means more acute events, more hospital admissions, and greater pressure on ambulance services and clinical teams to make fast, high-stakes decisions. The evidence base that informs those decisions needs to keep pace.

At ictaro, we have built our organisation specifically around the cardiovascular research field — including the acute end of it. With partners in more than 35 countries, connections to more than 200 hospitals and ambulance services, and a team that has navigated the complexity of pre-hospital and acute in-hospital trials, we understand what this environment requires. Not because we have applied a general CRO model to cardiovascular disease, but because we have worked in it for years.

The question for any sponsor considering an acute cardiovascular trial is not whether the science is ready. It is whether the team running it is.

Frequently asked questions

Acute care cardiovascular trials typically cover patients presenting with STEMI (ST-elevation myocardial infarction), NSTEMI (Non-ST-elevation myocardiual infarction), acute coronary syndrome (ACS), acute decompensated heart failure, and cardiogenic shock. Pre-hospital interventions — such as those initiated by ambulance services before hospital arrival — also fall within this category. The defining feature is that the patient is in or approaching a life-threatening event, and the research intervention must be initiated rapidly.

Several factors converge. Patient availability is unpredictable — you cannot schedule an acute MI. Enrolment must happen under time pressure, often in the ambulance or high-stress clinical environments. Standard informed consent processes may not be feasible when patients are incapacitated. Sites require 24/7 research coverage, which is operationally demanding and not universally available. And protocols must be compatible with urgent clinical workflows that cannot be paused for research procedures. Any one of these factors is manageable; all of them together require specialist operational planning.

Regulatory frameworks across Europe and internationally include provisions for emergency research consent. These include witnessed consent (where a legally authorised representative or independent witness provides consent on behalf of the patient), deferred consent (where the patient is enrolled and consented retrospectively once they are able), and exception from informed consent (EFIC) frameworks, which apply in specific circumstances where no consent is practicable. The appropriate mechanism depends on the country, the study design, and the patient population — and should be addressed during protocol development, not as an afterthought.

Beyond the standard criteria for any clinical trial site — adequate patient volume, trained staff, suitable facilities — acute care sites need specific capabilities: 24/7 access to a coronary care unit or cath lab, research coverage outside standard working hours, clinical staff with both the knowledge of the protocol and the capacity to implement it during emergency management. Site feasibility for acute trials requires a more granular assessment than for standard outpatient or elective studies.

Volume, workforce, and relationships. The service needs sufficient patient throughput to make participation viable, the capacity to train its entire paramedic workforce — not just a few designated individuals — and established relationships with the receiving hospitals a trial will depend on. Enthusiasm is a start. Infrastructure is what actually makes it work.

Yes — and the evidence suggests that, when done well, enrolment rates in acute settings can be surprisingly strong. Patients in acute cardiovascular events and their families often understand the urgency of the situation and are motivated to participate in research that may benefit others in similar circumstances. The barrier is less patient willingness and more operational readiness on the ambulance service, on the site and CRO side: the infrastructure, trained staff, and protocols that make enrolment possible at the right moment.

Our feasibility process for acute trials goes beyond ambulance service and site identification. We assess 24/7 research coverage capacity in practice, evaluate compatibility between the proposed protocol and existing clinical pathways, review local and national consent frameworks, and draw on our network of 200+ hospitals and ambulance services across Europe and beyond. We work with sponsors to identify and address operational risks before start-up — because in the acute setting, problems that emerge during enrolment are far harder to resolve than in chronic trial environments.

Meet the Ictaro Team at ACVC 2026 in Lisbon

This week, we will be heading to ACVC 2026 in Lisbon (20-21 march 2026)

Acute cardiovascular care is where every second counts, and it's one of the areas we're most passionate about at ictaro. From ambulance care to acute interventions, improving outcomes in these critical moments is exactly why clinical research matters.

ACVC26, organised by European Society of Cardiology, brings together the leading minds in the space of Acute cardiovascular care. Events like these help move the needle and that's why we're genuinely excited to be there — connecting, learning, and contributing to the conversation

Will we see you in Lisbon? Drop us a message — we'd love to connect.